NA 03.010.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982067845), received between Sep 13, 2019 and Mar 2, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break; Mechanical Problem

  DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE SMALL METAL SPRING WAS BROKEN ON THE HOLDING SLEEVE WHICH MADE THE DEVICE NO LONGER FUNCTION. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL, AND WAS SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487970 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT ROBE END IS BENT AND DENTED. HEX END OF SCREW SHAFT IS WARPED AND NOT USABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650689 ↗
• MalfunctionAug 31, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE LOAN KIT INSPECTION THE HOLDING SLEEVE WAS FOUND TO BE MISSING SPRING. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661304 ↗
• MalfunctionJul 10, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE SLEEVE WAS DETECTED TO BE INCOMPLETE. THIS REPORT IS FOR A HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288135 ↗
• MalfunctionOct 31, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 ,THAT THE THREADS ON ONE OF THE LOCKING NUTS WAS DAMAGED AND WOULDN¿T SCREW ON TO THE BARREL. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT EVENT OUTCOME/HOW WAS IT MANAGED: USED WITHOUT DEVICE THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLD-SL W/LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698580 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD STOCKING LOCATION (FSL), IT WAS OBSERVED THAT A HOLDING SLEEVE WITH LOCKING DEVICE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938835 ↗
• MalfunctionJun 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE INSERTING AN UNKNOWN DISTAL INTERLOCKING SCREW ON A HUMERAL NAIL, THE SURGEON ATTEMPTED TO USE A SCREW RETAINING SLEEVE. THE SCREW RETAINING SLEEVE DID NOT FUNCTION CORRECTLY AND WAS UNABLE TO BE USED. THE SURGEON HAD DIFFICULTY INSERTING THIS SCREW BECAUSE OF THE UNAVAILABILITY OF THE RETAINING SLEEVE. THE SCREW WAS ULTIMATELY INSERTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED. THERE WERE A 10 MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - NAILS: HUMERAL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096158 ↗
• MalfunctionJun 8, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HOLDING SLEEVE WITH LOCKING DEVICE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960693 ↗
• MalfunctionMay 5, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780322 ↗
• MalfunctionJun 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE HOLDING SLEEVE WITH LOCKING DEVICE WAS BROKEN. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10133508 ↗
• MalfunctionApr 8, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE HOLDING SLEEVE WITH LOCKING DEVICE WAS MISSING A PART. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9941583 ↗
• MalfunctionNov 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273241 ↗
• MalfunctionOct 29, 2019Use of Device Problem; Use of Device Problem

  LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, A HOLDING SLEEVE WITH LOCKING DEVICE DID NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9252728 ↗
• MalfunctionOct 22, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217684 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION THE HOLDING SLEEVE WITH LOCKING DEVICE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9124902 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION THE HOLDING SLEEVE WITH LOCKING DEVICE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE WITH LOCKING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9124881 ↗
• MalfunctionSep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, A HOLDING SLEEVE WITH LOCKING DEVICE WAS JAMMED, AND IT WOULD NOT RELEASE TO GRASP THE SCREW HEAD. THE MECHANISM HAD A SPRING AND BEARINGS INSIDE. THE SPRING WAS SUPPOSED TO COLLAPSE THE JAWS OF THE HOLDING SLEEVE OVER THE SCREW HEAD. THE HOLDING SLEEVE WAS STUCK IN THE OPEN POSITION. THE SALES REP MANAGED TO FREE THE SLEEVE AFTER THE CASE AND WAS ABLE TO MAKE IT WORK BUT IT SUBSEQUENTLY JAMMED AGAIN. THE SURGEON FIGURED OUT ANOTHER SOLUTION IN WHICH A VICRYL SUTURE WAS TIED TO THE SCREW WHEN IT WAS INSERTED THROUGH THE FAT AND SKIN THROUGH A SMALL INCISION. THIS METHOD WAS USED AS A FAIL-SAFE RETRIEVAL OF THE SCREW IN CASE SOMETHING GOES WRONG DURING INSERTION. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9049970 ↗