NA 03.010.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982067166), received between Dec 20, 2017 and Apr 11, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE BOLT COULD NOT BE INSERTED THROUGH THE INSERTION HANDLE AND AIMING ARM. THE SCREW PASSED THE NAIL ANTERIOR OR POSTERIOR AND DIDN'T FIT IN THE GLID HOLE.

  Patient problems: Insufficient Information

  MAUDE report 21824452 ↗
• MalfunctionJan 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CONNECTION SCREW GOT STUCK WITH THE COMPRESSION SCREW. THERE WAS NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129400 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS FOUND IN SPD THAT ITEMS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723667 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS FOUND IN SPD THAT ITEMS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723645 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE THREADS ON THE CONNECTING SCREWS ARE WORN OUT. THEY DO NOT ATTACH TO THE HANDLE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960375 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE THREADS ON THE CONNECTING SCREWS ARE WORN OUT. THEY DO NOT ATTACH TO THE HANDLE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960371 ↗
• MalfunctionMay 4, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGICAL TEAM ENCOUNTERED MULTIPLE ISSUES. 1) AIMING INSTRUMENTS TO LOCK THE ALFN NAIL PROXIMALLY WERE DAMAGED; LIKELY BENT. THE SURGEON WAS NOT ABLE TO TARGET THE NAIL HOLE(S) CORRECTLY. 2) THE WHOLE SET WAS IN BAD SHAPE AND DIRTY WHEN IT WAS IN THE OR. ALTHOUGH ALL THE INSTRUMENTS WERE PROCESSED BEFORE GETTING INTO THE OR ROOM, THE INSTRUMENTS WERE STILL DIRTY. WHEN THE SURGEON PRESSED THROUGH A CANNULATED INSTRUMENT OF THIS SET, SOME HUMAN MATERIAL CAME OUT. THE CUSTOMER ORDERED A NEW SET FROM ANOTHER HOSPITAL TO COMPLETE THE SURGERY. PATIENT SPENT AN EXTENDED AMOUNT OF TIME IN THE OR. THIS REPORT IS FOR A CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868416 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CONNECTING SCREWS FOR THE INSERTION HANDLES WERE CROSS THREADED AND VERY DIFFICULT TO UNSCREW OF THE IMPLANT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802409 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CONNECTING SCREWS FOR THE INSERTION HANDLES WERE CROSS THREADED AND VERY DIFFICULT TO UNSCREW OF THE IMPLANT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802400 ↗
• MalfunctionAug 18, 2021Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ONE OF THE GOLD HANDLES ON TARGETING ARM FOR THE RECON SCREWS FROM THE ALFN IS MISSING A SPRING; THEREFORE, IT IS NOT ABLE TO LOCK THE RECON SLEEVE CORRECTLY. ADDITIONALLY, THE CONNECTING SCREW THREADS ARE STRIPPED. THIS REPORT IS FOR A CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337693 ↗
• MalfunctionJun 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979810 ↗
• MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724995 ↗
• MalfunctionJan 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FEMUR NAILING WITH ADOLESCENT FEMORAL NAIL SYSTEM THE CONNECTING SCREW WOULD NOT THREAD INTO NAIL. THE CONNECTING SCREW APPEARED TO BE AN OLDER DESIGN WITH LESS THREADS. A SECOND CONNECTING SCREW WAS SELECTED AND WORKED AS PLANNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF 1 MINUTE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE THIS IS REPORT 1 OF 1 PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254499 ↗
• MalfunctionJan 22, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT ON AN UNKNOWN DATE, THE CANNULATED CONNECTION SCREW WAS DAMAGED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214629 ↗
• InjuryOct 15, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020 SEVERAL ISSUES OCCURRED INTRAOPERATIVELY WHICH INCLUDED DEVICE MALFUNCTIONS AND MISSING IMPLANT COMPONENTS. THE SURGEON NOTED THE MAIN IMPLANTS WERE MISSING ASSOCIATED LOCKING SCREWS. SOME OF THE SCREW LENGTHS WERE ON BACKORDER HOWEVER, THERE WERE OTHER LENGTHS OF SCREWS IN THE SET ADDITIONALLY, THE LONG T25 SCREWDRIVER WAS WORN AND WOULD NOT ENGAGE THE RECESS OF THE SCREWS WELL. THE CONNECTING SCREW FOR THE NAIL WAS WORN OUT AND DID NOT CONNECT TO THE IMPLANT PROPERLY. ALSO, DURING THE SURGERY, THE SURGEON USED THE AIMING GUIDE TO DRILL FOR THE PROXIMAL SCREWS. ONCE THE SCREWS WERE IMPLANTED, AN X-RAY WAS TAKEN AND IT WAS NOTED THAT THE SCREWS MISSED THE NAIL. THE SURGERY WAS DELAYED 60 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S NAIL. THIS IS REPORT 6 OF 7 (B)(4).

  Patient problems: No Code Available

  MAUDE report 10684770 ↗
• InjuryOct 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020 SEVERAL ISSUES OCCURRED INTRAOPERATIVELY WHICH INCLUDED DEVICE MALFUNCTIONS AND MISSING IMPLANT COMPONENTS. THE SURGEON NOTED THE MAIN IMPLANTS WERE MISSING ASSOCIATED LOCKING SCREWS. SOME OF THE SCREW LENGTHS WERE ON BACKORDER HOWEVER, THERE WERE OTHER LENGTHS OF SCREWS IN THE SET ADDITIONALLY, THE LONG T25 SCREWDRIVER WAS WORN AND WOULD NOT ENGAGE THE RECESS OF THE SCREWS WELL. THE CONNECTING SCREW FOR THE NAIL WAS WORN OUT AND DID NOT CONNECT TO THE IMPLANT PROPERLY. ALSO, DURING THE SURGERY, THE SURGEON USED THE AIMING GUIDE TO DRILL FOR THE PROXIMAL SCREWS. ONCE THE SCREWS WERE IMPLANTED, AN X-RAY WAS TAKEN AND IT WAS NOTED THAT THE SCREWS MISSED THE NAIL. THE SURGERY WAS DELAYED 60 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S NAIL. THIS IS REPORT 1 OF 7 (B)(4).

  Patient problems: No Code Available

  MAUDE report 10684086 ↗
• MalfunctionAug 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIA NAILING PROCEDURE ON (B)(6) 2020, THE UNKNOWN NAIL WAS STUCK ON THE GUIDE. THE SURGEON USED A VICE GRIPS TO REMOVE THE TARGETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365807 ↗
• MalfunctionAug 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIA NAILING PROCEDURE ON (B)(6) 2020, THE UNKNOWN NAIL WAS STUCK ON THE GUIDE. THE SURGEON USED A VICE GRIPS TO REMOVE THE TARGETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365806 ↗
• MalfunctionAug 31, 2018Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THE CANNULATED CONNECTING SCREW BETWEEN THE TIBIAL NAIL AND INSERTION HANDLE CROSS THREADED. THE CANNULATED CONNECTING SCREW WAS DISCONNECTED USING A CANNULATED SHAFT AND RATCHET WRENCH. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), TIBIAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837617 ↗
• MalfunctionAug 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE CONNECTING SCREW BETWEEN A TIBIAL NAIL AND INSERTION HANDLE FOR TITANIUM CANNULATED TIBIAL NAIL CROSS-THREADED DURING DISASSEMBLY. THE HEX SHAFT AND WRENCH WAS USED TO APPLY ENOUGH FORCE TO DISCONNECT THE NAIL FROM THE CONNECTING SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 15 MINUTES. PATIENT OUTCOME WAS NOT PROVIDED. CONCOMITANT DEVICES REPORTED: 9MM CANNULATED TIBIAL NAIL-EX 330MM (04.004.346S, LOT 7228397, QUANTITY 1), INSERTION HANDLE FOR TITANIUM CANNULATED TIBIA NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822303 ↗
• MalfunctionJul 23, 2018Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, THE CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE GOT JAMMED IN THE TIBIAL NAIL. THE CONNECTING SCREW WAS UNABLE TO LOOSEN FROM THE TIBIAL NAIL, REQUIRING A NEW TIBIAL NAIL AND CONNECTING SCREW. IT WAS UNCLEAR IF THE CONNECTING SCREW HAD STRIPPED. AFTER THE SURGERY WAS OVER, THE CONNECTING BOLT WAS SUCCESSFULLY DISCONNECTED FROM THE NAIL AFTER SEVERAL ATTEMPTS. NO PATIENT CONSEQUENCE WAS REPORTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710490 ↗
• MalfunctionMay 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE TIBIAL NAIL AND LOCKING SCREWS ON (B)(6) 2018, THE NAIL WOULD NOT DISCONNECT FROM THE STANDARD INSERTION HANDLE. THE BALL HEX SCREWDRIVER WAS BENT IN A 90-DEGREE ANGLE TO GET ENOUGH LEVERAGE TO RELEASE THE CANNULATED CONNECTING SCREW. AFTER INSPECTION, BOTH CANNULATED CONNECTING SCREWS WERE SHOWING SIGNS OF DISCREPANCIES. THERE WAS A SURGICAL DELAY OF TEN MINUTES. SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: BALL HEX SCREWDRIVER 8MM (PART: 03.010.092, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7553158 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CONNECTING SCREW FROM TIBIA-EX NAIL IS DIFFICULT TO SCREW/UNSCREW. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7364590 ↗
• MalfunctionFeb 23, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE FOR IMPLANTING A SYNTHES LATERAL ENTRY RECON NAIL ON (B)(6) 2018, A 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM WOULD NOT PASS THROUGH THE PROTECTION SLEEVES AND THE NAIL AS IT SHOULD. DURING THIS PROCESS, THE DRILL BIT BROKE INSIDE OF THE PATIENT BONE. THE BROKEN FRAGMENT OF THE DRILL BIT WAS RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT. ALSO, A RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX WAS NOT WORKING PROPERLY AS IT WAS MISALIGNED WITH NAIL, BUT PRIOR TO INSERTION OF FEMORAL NECK/HEAD COMPONENT, NAIL CONNECTION WAS CHECKED AND THE AIMING ARM CONNECTION WAS SECURED AS WELL. TWO OF THE 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING AND TWO 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING WERE ALSO NOT GUIDING THE DRILL BIT PROPERLY THROUGH THE NAIL. A STANDARD INSERTION HANDLE CONNECTED WITH THE AIMING ARM WASN'T WORKING PROPERLY AS THE SALES CONSULTANT HEARD SOME NOISE WHEN THE HANDLE WAS BEING USED. A CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE WAS NOT GETTING CONNECTED PROPERLY AND A 5.0MM FLEXIBLE SHAFT WAS NOT ABLE TO PASS OVER A 2.5MM REAMING ROD. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND THE SURGEON WAS U

  Patient problems: Not Applicable

  MAUDE report 7293463 ↗
• MalfunctionFeb 8, 2018Fitting Problem; Device Operates Differently Than Expected; Fitting Problem; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CONNECTION SCREW DOES NOT FIT WELL, IS SCREWING BADLY, DUE TO THE NET. THERE IS NO PATIENT HARM REPORTED AND NO OTHER INFORMATION PROVIDED AT THIS TIME. THIS COMPLAINT INVOLVED ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7253062 ↗