MULTILOC 03.019.007Recalls & reported problems
Synthes GmbH · CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL · Class 2
All models of MULTILOC (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes Multiloc connecting screw is used to attach a screw to a Multiloc humeral nail during surgery to fix a broken upper arm bone. Most reports describe the screw or other instruments breaking during the operation, sometimes leaving a broken piece trapped inside the nail and delaying surgery, along with parts not fitting together properly and instruments arriving with residue inside them. There are 36 reports, with 5 injuries and no deaths. No recalls name this device. Reports fell sharply in the past year, from 10 to 1.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886982069443), received between Mar 16, 2017 and Sep 22, 2026 — classified as 5 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Break” (15 reports).
2 other recalls cover devices cleared under the same FDA submission (K103002); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break15
- Device-Device Incompatibility15
- Contamination /Decontamination Problem5
- Entrapment of Device5
- Material Twisted/Bent2
- Corroded1
- Crack1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Foreign Body In Patient5
- No Consequences Or Impact To Patient4
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Laceration(s)1
- No Code Available1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862718 ↗MalfunctionAug 3, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114742 ↗MalfunctionJun 17, 2026Break; Entrapment of Device
IT WAS REPORTED THAT DURING ORIF OF THE RIGHT HUMERUS, THE TIP OF THE CANNULATED CONNECTING SCREW BROKE WHILE THE SURGEON WAS COMPRESSING THE SCREW. THE SCREW TIP HAD BROKEN OFF AND WAS RETAINED INSIDE THE IMPLANTED HUMERAL NAIL, CAUSING OBSTRUCTION; THE END CAP COULD NOT BE INSERTED.
Patient problems: Foreign Body In Patient
MAUDE report 25535786 ↗MalfunctionSep 11, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE SURGEON REALIZED THAT THE NAIL WAS VERY SUNK IN THE MEDULLARY CHANNEL, SO HE MADE THE DECISION TO TAKE IT OUT A LITTLE. WHEN USING THE HAMMER OF THE EQUIPMENT, THE PIECE OF IMPACTOR WAS BROKEN, AT THE TIME OF TAKING IT AND CHECKING IT, IT WAS NOTED THAT THE PIECE BROKE, LEAVING THE REST IN THE FASTENING SCREW THE NAIL.
Patient problems: Foreign Body In Patient
MAUDE report 23027345 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTION SCREW HAD A CRITICAL FAILURE: THE CONNECTING SCREW BROKE WHEN INSERTED TO THE NAIL. AT THE MOMENT OF ANCHORING BOTH PIECES, CONNECTION SCREW AND IMPLANT WITH MINIMAL FRICTION, THIS PIECE SUFFERED DAMAGE BROKE INTO TWO PARTS, LEAVING ONE OF THESE INSIDE THE IMPLANT, FOR THAT REASON, THE PROCEDURE COULD NOT END SUCCESSFULLY WITH THIS CONTAINER OF INSTRUMENTS AND IT WAS NECESSARY TO REQUEST ANOTHER CONTAINER OF NAIL, MULTILOC TO SOLVE THE SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849572 ↗MalfunctionJul 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HOSPITAL RECEIVED MULTILOC NAIL INSTRUMENTS THAT HAD BEEN POORLY CLEANED. RESIDUE WAS FOUND INSIDE THE CONNECTING SCREW, CANNULATED, FOR MULTILOC HUMERAL NAIL. THERE WAS NO PROBLEM WITH THE IMPLANTS, ONLY WITH THE INSTRUMENTS USED TO PLACE THE IMPLANTS. THE INSTRUMENTS WERE DISINFECTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468376 ↗MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH A MULTILOC NAIL FOR A FRACTURE OF THE PROXIMAL END OF THE LEFT HUMERUS. WHEN THE PRODUCTS WERE CHECKED BEFORE NAIL INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN THE PROXIMAL HOLE. WHEN THE NAIL WAS REMOVED FROM THE DEVICES AND REASSEMBLED, THE INTERFERENCE IN HOLES A AND B WAS RESOLVED, BUT THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN HOLES D, F, AND G. DRILLING WAS SUCCESSFULLY DONE WITHOUT INTERFERENCE BETWEEN THE DRILL BIT AND THE NAIL, AND SCREWS WERE ALSO SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22233353 ↗MalfunctionJun 13, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SURGEON WAS TRYING TO REMOVE THE MULTILOC NAIL FROM THE HUMERUS BECAUSE IT WAS TOO LONG. WHILE BACKSLAPPING, THE CONNECTING SCREW BROKE. THERE WAS A 70 MINUTES OF SURGICAL DELAY. MORE X-RAYS WERE TAKEN AND MORE TIME TO COMPLETE THE PROCEDURE WAS INVOLVED,. NEW NAIL IN WITH THE NAIL EXTRACTION DEVICE AND PERFORMED PERFECT CIRCLES FOR OUR CROSS LOCK SCREWS. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203220 ↗MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH A MULTILOC SHORT NAIL. DURING AN INTERFERENCE CHECK BEFORE IMPLANT INSERTION INTO THE BODY, A SCRUB NURSE POINTED OUT THAT THE DRILL BIT FELT A LITTLE LIKE IT WAS TOUCHING THE NAIL IN THE D-HOLE. THE INSTRUMENTS AND NAIL WERE REASSEMBLED FROM THE BEGINNING AGAIN, AND THE SURGEON PERFORMED AN INTERFERENCE CHECK AGAIN. THE INTERFERENCE IN THE D-HOLE WAS RESOLVED, BUT THE SURGEON POINTED OUT THAT THERE WAS A SLIGHT FEELING THAT THE DRILL BIT WAS TOUCHING THE NAIL IN THE G-HOLE. IT WAS DECIDED THAT INTERFERENCE COULD BE AVOIDED BY ADJUSTING THE DIRECTION OF DRILLING, AND THE NAIL WAS INSERTED AT THE SURGEON'S DISCRETION. DRILLING WAS PERFORMED PROXIMALLY AND DISTALLY WITHOUT INTERFERENCE WITH THE NAIL, THE SCREW WAS INSERTED, AND FIXATION WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22174583 ↗MalfunctionMay 12, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTING SCREW BROKE OFF IN A NAIL WHICH RESULTED IN THE AIMING ARM NOT PERFORMING CORRECTLY. PROCEDURE WAS COMPLETED BUT IT CAUSED SIGNIFICANT DELAY IN SURGERY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22002640 ↗MalfunctionFeb 26, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTING SCREW FOR THE MULTILOC NAIL BROKE WHEN REMOVING IT AFTER THE OPERATION. JUST THE THREADS BROKE OFF IN THE TOP OF THE NAIL. THERE WAS NO DELAY TO OPERATION.
Patient problems: Insufficient Information
MAUDE report 21468735 ↗MalfunctionJan 27, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED PRODUCT DAMAGE HAS BEEN IDENTIFIED ON AN UNKNOWN DATE DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241487 ↗MalfunctionJan 8, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE END OF THE CONNECTION SCREW BROKE IN TWO DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024. IT WAS NOTED IT WAS UNABLE TO BE USED FOR BOTH NAILING AND POSITIONING THE SCREWS AFTERWARDS.
Patient problems: Foreign Body In Patient
MAUDE report 21105472 ↗MalfunctionSep 26, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, IN THE SURGERY WITH MULTILOC NAIL, THE FAILURE OF AN INSTRUMENT OF THE SYSTEM (SCREW CONNECTING TO THE NAIL) OCCURRED AND THE INTRAOPERATIVE SURGERY HAD TO BE SUSPENDED. THE PATIENT WILL HAVE TO OPERATE ANOTHER DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20311227 ↗MalfunctionSep 17, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE CONNECTING SCREW FOR MULTILOC SEEMED TO CROSS THREAD INTO THE NAIL AND WAS UNABLE TO CONNECT NAIL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237784 ↗MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725763 ↗MalfunctionJun 14, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN EMERGENCY ROOM PROCEDURE, THE DEVICE BROKE. NO FURTHER INFORMATION PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19537585 ↗MalfunctionJun 10, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON UNKNOWN DATE THE ITEMS HAD RUST AND WHITE RESIDUE DUE TO SPRAY OF STERILIZER TO LUBRICATE ITEMS. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE CONNECTING SCRECANN FOR MULTILOC HUM NL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497669 ↗MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A MULTILOC PROCEDURES, THE DRILL BIT HIT THE NAIL FOR THE POSTERIOR, ANTERIOR AND DIRECT ANTERIOR SCREW. THE SLEEVES WERE TESTED BEFORE AND UNSURE WHAT HAPPENED. PERFECT CIRCLE PROCEDURE WAS PERFORMED PROXIMALLY. THERE WAS A PATIENT DELAY. IT WAS UNSURE THAT THE JIG WAS BENT OR NOT DUE TO ROTATING JIG INTRAOP, BUT SURGEON WANTS EVERYTHING REPLACED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CONNECTING SCRECANN FOR MULTILOC HUM NL THIS IS REPORT 5 OF 9 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18633042 ↗MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT THE ORIF WITH THE MULTILOC. DURING DRILLING, THE DRILL BIT INTERFERED WITH THE NAIL. AT FIRST, THREE MULTLOC SCREWS WERE INSERTED INTO THE PROXIMAL AREA. THEN, THE DISTAL LOCKING SCREW WAS INSERTED INTO THE LEVEL G HOLE. THE DRILL BIT AND THE SCREW WERE INTERFERED WITH THE NAIL AT THE LEVEL F HOLE. THE SURGEON CHECKED FOR LOOSENING ON THE CONNECTING SCREW AND THE AIMING ARM, AND THERE WERE NO PROBLEMS. HAMMERING WAS NOT PERFORMED FOR THIS SURGERY. THE SURGEON COMMENTED THAT HE FELT LIKE THE DRILL BIT WAS HITTING THE NAIL. THE DRILL BIT WENT THROUGH THE HOLE THROUGH THE AIMING ARM, THE DRILL SLEEVE, AND PROTECTION SLEEVE. HOWEVER, WHEN THE SCREW WAS INSERTED, IT WENT OUTSIDE THE NAIL. THE SURGEON DETERMINED THAT THE DRILL BIT DID NOT PASS THROUGH THE HOLE IN THE NAIL, SO THAT THE SURGEON MANUALLY DRILLED THE HOLE AND INSERTED IT. THE INSERTION OF THE DEVICES WAS NOT CHECKED BEFORE INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE ARE NO FRAGMENTS IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THIS IS FOR AN CONNECSCR CANN F/MULTIL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18291882 ↗MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT AND THE SCREW DIDN´T ACHIEVE THE NAIL´S HOLE IN THE MULTILOC HUMERAL NAIL SYSTEM. THE SURGEON MISSED THE PROXIMAL POSTERIOR OBLIQUE HOLE AND THE DISTAL ANTERIOR OBLIQUE HOLE. THE AIMING ARM FOR PROXIMAL HUMERAL NAIL, THE INSERTION HANDLE, AND THE CONNECTING SCREW HAD BEEN USED. THE AIMING ARM WAS ON THE CORRECT SIDE (RIGHT SIDE). THE SURGERY HAS BEEN DELAYED 1 HOUR, AND THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16635866 ↗MalfunctionMar 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, IS WAS DISCOVERED THAT THE INSTRUMENT WAS STILL DIRTY; DIRT CAME OUT WHEN USING THE GUIDE PIN. THERE IS POTENTIAL RISK FOR INFECTION TO THE PATIENT HOWEVER, THERE HAS BEEN NO PATIENT CONSEQUENCE TO DATE. THIS REPORT IS FOR A CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522295 ↗InjuryJan 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE PROXIMAL FRACTURE OF THE RIGHT HUMERUS. PROXIMAL A HOLE AND B HOLE WERE FIXED. DISTAL F HOLE WAS FIXED. THEN, WHEN THE SURGEON WAS DRILLING G HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. ALTHOUGH THE SURGEON CONTINUED DRILLING WHILE APPLYING SLIGHT AXIAL PRESSURE, THE DRILL BIT DISENGAGED FORWARD. AFTER CHECKING THE CONNECTING SCREW AND THE AIMING ARM FOR LOOSENESS, SKIN INCISION AT G HOLE WAS EXTENDED. THE SLEEVE WAS REINSERTED WHILE DODGING THE SOFT TISSUE PART. ALTHOUGH DRILLING WAS PERFORMED WHILE CONTROLLING THE DRILL TO HEAD BACKWARD, THE DRILL HOLE DISLODGED ANTERIOR TO INTRAMEDULLARY NAIL. THE SURGEON REMOVED THE AIMING ARM, AND DRILLING WAS PERFORMED MANUALLY. THEN, THE SCREW WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)CONNECSCR CANN F/MULTILOC HUM NAIL SYST. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Laceration(s)
MAUDE report 16241789 ↗MalfunctionApr 14, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HOLLOW PART ON THE CONNECTING SCREW DEVICE WAS STAINED EVEN IT WAS WIPED WITH A COTTON SWAB. IT WAS FURTHER REPORTED THAT THE DEVICE HAD DIRT CAME OUT EVEN AFTER CAREFULLY CHECKING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CONNECSCR CANN F/MULTILOC HUM NAIL SYST. THIS COMPLAIN INVOLVES ONE(1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14115395 ↗MalfunctionJan 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR SURGICAL NECK FRACTURE OF THE HUMERUS. BEFORE THE SURGERY, WHEN THE SALES REP EXPLAINED ABOUT THE DRILL SLEEVE TO A NURSE, SOMETHING LIKE A BLOOD CLOT CAME OUT OF THE DRILL SLEEVE. THE DRILL SLEEVE WAS CLEANSED AND RE-STERILIZED. DURING THE SURGERY, WHEN THE SURGEON INSERTED A NAIL USING A GUIDE ROD AND PASSING THE CONNECTING SCREW INTO THE NAIL, A BLOOD CLOT CAME FLYING. THE GUIDE ROD IN THE UNCLEAN AREA WAS CUT, THE CONNECTING SCREW WAS REMOVED, AND THE CONNECTING SCREW WAS CLEANSED AND STERILIZED AGAIN. THE SURGEON TOOK ADVANTAGE OF THE TIME THAT CONNECTING SCREW WAS BEING RE-STERILIZED TO REMOVE THE ILIUM. HOWEVER, THE TIME FOR RE-STERILIZATION TOOK LONGER THAN THAT, SO THERE WAS A TIME WHEN THE PROCEDURE COULD NOT BE PROCEEDED. THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. IT IS POSSIBLE THAT THIS EVENT WAS CAUSED BY AN INSUFFICIENT CLEANSING AT ANOTHER HOSPITAL THAT USED THE SAME PRODUCTS BEFORE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONNECTING SCREW/CANNULATED FOR MUL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13179731 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103002. One submission often covers many models, so check the product and lot details in each record.
- Z-2059-2012 · May 22, 2012 · Terminated4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
- Z-2060-2012 · May 22, 2012 · Terminated4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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