NA 03.010.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982067180), received between Jul 9, 2015 and Mar 20, 2024 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024, THAT THE CONNECTING ASPECT OF INSERTION HANDLE BROKE OFF WHEN ATTEMPTING TO INSERT NAIL DURING A CASE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942770 ↗
• MalfunctionJan 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED AFTER A LATERAL FEMORAL NAIL PROCEDURE ON (B)(6) 2023, THE INSTRUMENT WAS BROKEN POST-OPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A PERCUTANEOUS INSERTION HANDLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474507 ↗
• MalfunctionApr 17, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE (B)(6) 2023, A NOSE COMPONENT OF PERCUTANEOUS INSERTION HANDLE BROKE WHEN IT WAS SEPARATED FROM THE NAIL. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752200 ↗
• MalfunctionMay 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE THE SURGEON WAS PERFORMING AN IM NAIL OF A FEMUR USING THE LATERAL ENTRY FEMORAL NAIL. AS THE SURGEON WAS ROTATING THE AIMING ARM FOR THE NAIL IT BROKE LOOSE. AFTER REALIZING THE AIMING ARM WAS NO LONGER SECURELY ATTACHED TO THE FEMORAL NAIL, THE SURGEON HAD TO PERFORM A PERFECT CIRCLE TECHNIQUE TO PLACE HIS PROXIMAL LOCKING SCREWS. THERE WAS 5 MINUTES OF SURGICAL DELAY. FRAGMENTS WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - NAILS: FEMORAL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14368799 ↗
• MalfunctionMay 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 20201 THAT THE PROTECTION SLEEVE COULD NOT BE ATTACHED TO THE AIMING ARM BECAUSE IT COULD NOT BE PLACED OVER THE INSERTION HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY FREE HAND WHICH RESULTED IN A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PATIENT OUTCOME WAS GOOD AND AS EXPECTED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784135 ↗
• MalfunctionOct 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE PERCUTANEOUS INSERTION HANDLE HAS MISALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR 1 PERCUTANEOUS INSERTION HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10762173 ↗
• InjuryJan 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING LATERAL ENTRY FEMORAL NAIL (LEFN) PART REPLACEMENT SURGERY THE TOOTH CAME OFF FROM PERCUTANEOUS INSERTION HANDLE. IT WAS NOT RECOVERED. THERE WAS NO PROCEDURE DELAY AND WAS SUCCESSFULLY COMPLETED. NO KNOWN FRAGMENTS. PATIENT STATUS AND OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8287247 ↗
• MalfunctionMay 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A TIBIA NAIL PROCEDURE ON (B)(6) 2018 WHILE PUTTING TOGETHER THE PERCUTANEOUS INSERTION HANDLE AND AIMING ARM TOGETHER IT WAS FOUND THAT THE PERCUTANEOUS INSERTION HANDLE HAS A HOLE THAT IS OBLONG AND WOULD NOT ALLOW THE AIMING ARM TO BE INSERTED. ANOTHER SET WAS READILY AVAILABLE. WHILE USING THE INSERTION HANDLE WITH THE DRIVING CAP THE THREADED PART OF THE DRIVING CAP BROKE OFF INTO THE INSERTION HANDLE. THERE WERE ADDITIONAL INSTRUMENTS AVAILABLE TO COMPLETE THE SURGERY. THE PATIENT¿S OUTCOME WAS GOOD. THERE WAS A DELAY IN SURGERY BUT IT IS UNKNOWN THE LENGTH OF TIME. THERE WAS NO MEDICAL INTERVENTION, UNANTICIPATED X-RAYS AND NO FRAGMENTS GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7488820 ↗
• MalfunctionApr 12, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE 12.0MM/8.00 MM PROTECTION SLEEVE WILL NOT INSERT THROUGH THE HOLE LABELED ¿120 DEGREES¿ ON THE PERCUTANEOUS INSERTION HANDLE. THERE IS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7427140 ↗
• InjuryApr 5, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) TO TREAT THE DISTAL FEMUR FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE THE TWO (2) DISTAL SCREWS MISSED THE NAIL HOLE (RAFN) WHICH CAUSED THE SCREWS INSERTED POSTERIORLY. THE CONNECTING SCREW WAS TIGHTLY SECURED TO THE INSERTION HANDLE AND PRE-CHECKING OF THE NAIL AND JIG ALIGNMENT WAS DONE AND IT WAS ALIGNED PERFECTLY. SURGEON DOESN¿T KNOW WHY THE JIG WOULD HAVE MISSED THE NAIL, GIVEN THAT THE CONNECTING SCREW WAS TIGHT TOO. THE SURGEON HAD TO REMOVE THE 2 SCREWS AND REPLACE IT WITH A SPIRAL BLADE FOR THE NAIL. THERE WAS A THREE (3) MINUTE SURGICAL DELAY TO THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7399650 ↗
• MalfunctionDec 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PERCUTANEOUS INSERTION HANDLE WAS DISCOVERED DAMAGED IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. SALES CONSULTANT TRIED TO PUT AN 8MM PROTECTION SLEEVE THROUGH THE TARGETING HOLE OF THE INSERTION HANDLE AND IT WOULD NOT FIT. THE INSERTION HANDLE CANNOT BE USED IN ANY PROCEDURES. THE INSERTION HANDLE IS LIKELY BENT RIGHT AT THE TARGETING HOLE. THE SALES CONSULTANT TRIED SEVERAL PROTECTION SLEEVES ON THE REPORTED INSERTION HANDLE AND THEY WOULD NOT FIT THROUGH THE TARGETING HOLD. THE SAME PROTECTION SLEEVES WERE USED ON A DIFFERENT INSERTION HANDLE AND ALL OF THE PROTECTION SLEEVES FIT. THE ISSUE APPEARS TO BE WITH THE INSERTION HANDLE AND NOT THE PROTECTION SLEEVES. CONCOMITANT DEVICE REPORTED: 12.0MM/8.0MM PROTECTION SLEEVE 188MM (03.010.063, LOT UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138544 ↗
• MalfunctionDec 18, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017, THE INSERTION HANDLE WAS USED TO INSERT A LATERAL ENTRY FEMORAL NAIL. DURING INSERTION INTO A TIGHT CANAL, THE SURGEON ROTATED THE NAIL AND SNAPPED THE ALIGNMENT TOOTH OFF OF THE INSERTION HANDLE. THE PIECE WAS REMOVED AND THE SURGERY WAS DELAYED BY FIFTEEN (15) MINUTES. THE NAIL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: LATERAL ENTRY FEMORAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7125240 ↗
• MalfunctionDec 14, 2017Break; Break

  IT WAS REPORTED THAT DURING A REVISION OF A RETROGRADE/ANTEGRADE FEMORAL NAIL (R/AFN) PROCEDURE DUE TO NON-UNION, THE TIP OF THE PERCUTANEOUS INSERTION HANDLE BROKE OFF. THE BROKEN PIECE COULD NOT BE FOUND ANYWHERE. X-RAYS WERE PERFORMED BUT IT COULD NOT BE CONFIRMED THAT THE PIECE STAYED IN THE PATIENT. THERE WAS A 15-MINUTE SURGICAL DELAY. THE PATIENT STATUS IS REPORTED AS STABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO ADDITIONAL INFORMATION. THE POSTOPERATIVE ISSUE OF NONUNION HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119367 ↗
• MalfunctionDec 5, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE TROCAR FROM A PERCUTANEOUS INSERTION HANDLE WOULD NOT GO THROUGH THE 120-DEGREE HOLE AS INTENDED. THE TROCAR WAS TESTED ON OTHER INSERTION HANDLES WITHOUT ANY DIFFICULTY. THIS WAS NOTICED DURING ROUTINE INSPECTION. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE: TROCAR (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084975 ↗
• MalfunctionNov 15, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT MULTIPLE INSTRUMENTS MALFUNCTIONED DURING A LATERAL ENTRY FEMORAL NAILING TO REPAIR A MIDSHAFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT ON (B)(6) 2017. AFTER THE SURGEON INSERTED THE NAIL, HE INSERTED THE THREE-PART TROCAR ASSEMBLY, HE THEN CHECKED TO MAKE SURE IT WAS BEING TARGETED CORRECTLY. WHEN HE WENT TO INSERT THE GUIDE WIRE, IT KEPT HITTING THE NAIL AND WAS MISALIGNED. THE MISALIGNMENT ISSUE ONLY HAPPENED WITH ONE GUIDE WIRE AND FIRST SET OF THE THREE-PART TROCAR ASSEMBLY. LATER IN THE PROCEDURE, HE ATTEMPTED TO TAKE THE NAIL OUT, BUT THE HAMMER KEPT GETTING JAMMED AND WOULDN¿T ROCK BACK AND FORTH ON THE HAMMER GUIDE, HE STRUGGLED TO GET THE NAIL OUT. THEN, AS THE DEPTH GAUGE WAS BEING USED TO MEASURE THE LENGTH OF THE RECON SCREWS; THE SURGEON TRIED THREE TIMES AND THE MEASUREMENT WAS INACCURATE, IT WAS 10MM LONGER THAN NEEDED. THERE WAS A REPORTED SURGICAL DELAY OF 10 MINUTES TO TAKE THE NAIL OUT AND REPOSITION IT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES NINE (5) DEVICES. CONCOMITANT DEVICES REPORTED: HAMMER GUIDE (PART# UNK

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7035653 ↗
• InjuryJul 28, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE INSERTION HANDLE BROKE DURING A LATERAL ENTRY FEMORAL NAILING PROCEDURE ON (B)(6) 2017. THE SURGEON HAD PERFORMED THE PROCEDURE PER THE TECHNIQUE GUIDE BUT DID NOT LIKE THE WAY THE NAIL WAS SEATED IN THE FEMUR AND OPTED TO REMOVE IT DESPITE NO ALLEGATION OF DEFICIENCY OR MALFUNCTION AGAINST THE NAIL. THE SURGEON OPTED TO REMOVE THE NAIL AND WANTED TO ¿START OVER¿ WITH A NEW NAIL. DURING THE REMOVAL OF THE NAIL, THE APPROXIMATE 1MM X 1MM TAB THAT KEEPS THE NAIL FROM ROTATING ON THE HANDLE BROKE OFF AND WAS LOST IN THE PATIENT¿S BONE. SURGEON DECIDED NOT TO REMOVE THE FRAGMENT. THE NAIL WAS REMOVED INTACT WITH NO ALLEGATION OF DEFICIENCY/MALFUNCTION AND WAS THEN DISCARDED. THE SURGEON THEN RE-REAMED THE BONE USING A DIFFERENT TECHNIQUE AND INSERTED A NEW NAIL OF THE SAME SIZE WITHOUT DIFFICULTY. THERE WAS NO REPORTED SURGICAL DELAY AND NO ADDITIONAL X-RAYS WERE REQUIRED. IT IS NOTED THAT THIS WAS A DIFFICULT CASE BUT WAS PERFORMED IN ACCORDANCE WITH THE TECHNIQUE GUIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: FEMORAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); MALLET (PART NU

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6752159 ↗
• MalfunctionJul 6, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A LATERAL ENTRY FEMORAL RECONSTRUCTION NAIL PROCEDURE, THE SURGEON BACKED THE NAIL OUT A SHORT DISTANCE BY HITTING THE UNDERSIDE OF THE INSERTION HANDLE WITH A MALLET. THE MALLET DAMAGED THE HOLE THAT THE LOCKING SLEEVE GOES THROUGH, MAKING THE HOLE DISTORTED AND UNABLE TO ACCEPT ANY OTHER LOCKING SLEEVES. THE SURGERY WAS COMPLETED SUCCESSFULLY BY LOCKING THE NAIL IN A DIFFERENT WAY. THERE WERE NO FRAGMENTS GENERATED, NO SURGICAL DELAY REPORTED, AND NO REPORTED HARM TO THE PATIENT. THE PATIENT'S OUTCOME WAS STABLE FOLLOWING THE SURGERY. REPORTED CONCOMITANT PARTS: LATERAL ENTRY FEMORAL RECON NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); LOCKING SLEEVE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); MALLET (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6689189 ↗
• MalfunctionApr 28, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE INSERTION HANDLE WAS DISCOVERED BROKEN PRIOR TO THE START OF SURGERY ON (B)(6) 2017. THE PIECE AT THE TIP OF THE INSERTION HANDLE THAT COMES IN CONTACT WITH THE NAIL HAD BROKEN OFF. THE PATIENT HAD BEEN WHEELED INTO THE OPERATING ROOM; HOWEVER, THE DEVICE DID NOT COME NEAR THE PATIENT. THE PIECE THAT BROKE OFF COULD NOT BE LOCATED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530449 ↗
• MalfunctionApr 6, 2017Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF SYNTHES FIELD EQUIPMENT, IT WAS DISCOVERED THAT THE TOOTH OF THE AIMING ARM (COMPONENT THAT CONNECTS TO THE ROD) WAS BROKEN OFF AND MISSING. IT IS UNKNOWN WHEN THE INSTRUMENT WAS LAST USED AND WHEN THE DAMAGE OCCURRED. THERE WAS NO REPORT OF PATIENT OR PROCEDURAL INVOLVEMENT ASSOCIATED WITH THE COMPLAINT EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6470691 ↗
• MalfunctionJan 4, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT A TROCAR WILL NOT GO THROUGH THE 120 DEGREE HOLE IN AN INSERTION HANDLE; THE TROCAR IS HARD TO PUT IN AND THEN GETS STUCK WHEN REMOVED FROM THE HANDLE. HAMMER MARKS ARE VISIBLE ON BOTH INSTRUMENTS, AND THE LIP IS BENT IN THE HOLE OF THE INSERTION HANDLE. THIS WAS NOTICED IN STERILE PROCESSING DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6222010 ↗
• MalfunctionJul 9, 2015Break

  DEVICE REPORT SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSERTION HANDLE BROKE AT THE BEGINNING OF THE SURGERY, WHILE CONNECTING THE NAIL TO THE INSERTION HANDLE WITH NO EFFECT ON THE PATIENT. THE REPORTED EVENT RESULTED IN A 10 MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 4903242 ↗