MULTILOC 03.019.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982069504), received between May 16, 2019 and Jan 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PROTECT SLEEVE 13/10 L150, HAD AN ISSUE WHERE THE OUTER TUBE WOULD NOT PROPERLY FIT DURING INTRA-OPERATIVE USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969133 ↗
• MalfunctionJul 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2024 THE TROCAR IS BENT AND NEEDS TO BE REPLACED. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 13/10 PROTC SLV 4.5 TI MULTILOC SCR/150. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668837 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT SPECTROSCOPIC FRACTURE SURGERY FOR A FRACTURE OF THE UPPER WRIST BONE TRUNK WITH THE PRODUCT IN QUESTION. DURING MHN LONG OPERATION, WHEN ITEM 03.019.013, PROTECTION SLEEVE FOR 13.0/10.0 MULTILOC SCREW, WAS PASSED THROUGH THE B HOLE D HOLE OF THE PRODUCT IN QUESTION, ONLY HALF OF THE SLEEVE WAS PASSED. ITEM 03.019.008, AIMING ARM FOR MULTILOC WAS SUBSTITUTED, AND THE SURGERY PROCEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 13.0MM/10.0MM PROTECTION SLV F/4.5MM TI MULTILOC SCR/150MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723914 ↗
• MalfunctionNov 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UTTER TROCAR FOR MULTILOC SCREWS WILL NO LONGER HOLD MIDDLE SLEEVE. IT WAS DISCOVERED IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 13/10 PROTC SLV 4.5 TI MULTILOC SCR/150. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752724 ↗
• MalfunctionOct 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE PROTECTION SLEEVES IN QUESTION. DURING THE SURGERY, THE SURGEON HAD A DIFFICULTY INSERTING THE PROTECTION SLEEVES INTO B HOLE OF THE AIMING ARM (03.019.008), AND IT TOOK A LONG TIME TO REACH THE BONE. THE SURGEON ALSO HAD A DIFFICULTY REMOVING THE PROTECTION SLEEVES TOO. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM A(PART# UNKNOWN, LOT# UNKNOWN, QTY UNK) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)13.0MM/10.0MM PROTECTION SLV F/4.5MM TI MULTILOC SCR/150MM. THIS REPORT IS 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650874 ↗
• MalfunctionOct 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONFIRMED BY CT THAT THE PROXIMAL SCREW WAS NOT INSERTED PROPERLY. THE REVISION SURGERY WILL NOT BE PERFORMED BECAUSE THERE WAS NO PROBLEM ABOUT FIXATION. THE SURGEON COMMENTED THAT THE SLEEVE MIGHT NOT BE INSERTED PROPERLY DUE TO MUSCLE REPELLING. THERE WAS NO PROBLEM ABOUT THE DEVICES BEFORE USE. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: AIMING ARM (PART# 03.019.008, LOT# 9856260, QUANTITY 1). DRILL SLEEVE (PART# 03.019.014, LOT# 8404272, QUANTITY 2). TROCAR (PART# 03.019.015, LOT# 8352173, QUANTITY 1). TROCAR (PART# 03.019.015, LOT# 8352171, QUANTITY 1). AIMING ARM KNOB (PART# 03.019.030, LOT# 8345524, QUANTITY 1). THIS REPORT IS FOR ONE (1) 13.0MM/10.0MM PROTECTION SLV F/4.5MM TI MULTILOC SCR/150MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684020 ↗
• MalfunctionMay 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON APRIL 17, 2019 DURING AN INSPECTION AT STERILE PROCESSING DEPARTMENT, THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AIMING ARM KNOB, THREE (3) DRILL SLEEVE AND THREE (3) PROTECTION SLEEVE OF THE MULTILOC HUMERAL NAIL INSTRUMENTS DID NOT ACCURATELY TARGET HOLES IN NAIL WITH DRILL BITS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8615726 ↗
• MalfunctionMay 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2019 DURING AN INSPECTION AT STERILE PROCESSING DEPARTMENT, THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AIMING ARM KNOB, THREE (3) DRILL SLEEVE AND THREE (3) PROTECTION SLEEVE OF THE MULTILOC HUMERAL NAIL INSTRUMENTS DID NOT ACCURATELY TARGET HOLES IN NAIL WITH DRILL BITS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8615719 ↗
• MalfunctionMay 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON APRIL 17, 2019 DURING AN INSPECTION AT STERILE PROCESSING DEPARTMENT, THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AIMING ARM KNOB, THREE (3) DRILL SLEEVE AND THREE (3) PROTECTION SLEEVE OF THE MULTILOC HUMERAL NAIL INSTRUMENTS DID NOT ACCURATELY TARGET HOLES IN NAIL WITH DRILL BITS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8615579 ↗