NA 04.005.516Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982085849), received between Mar 16, 2018 and Sep 5, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF THREE (3) TITANIUM (TI) MULTILOC SCREWS DUE TO LEFT SHOULDER PAIN. ALL OF THE SCREWS WERE REMOVED INTACT WITHOUT ANY PROBLEM. THE MULTILOC HUMERAL NAIL WAS LEFT IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE NAIL IN PLACE AS IT WAS NOT STICKING OUT NOR WAS THERE A MALFUNCTION WITH AND HE FELT THE SCREWS WERE THE CAUSE OF THE PAIN. IT WAS NOT PROVIDED IF THERE WAS ANY OTHER MEDICAL INTERVENTION DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS NOT PROVIDED. CONCOMITANT DEVICE: MULTILOC HUMERAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 5.0 MM TI LOCKING SCREW WITH T25 STARDRIVE 26 MM FOR INTRAMEDULLARY (IM) NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7847559 ↗
• MalfunctionMar 16, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN ANKLE ARTHRODESIS PROCEDURE ON (B)(6) 2018, AS THE SURGEON ATTEMPTED TO INSERT TWO (2) LOCKING SCREWS INTO THE NAIL, THERE WAS A MISALIGNMENT ISSUE. THE DRILL BIT WOULD NOT ALIGN WITH THE NAIL. SURGEON DECIDED TO USE PERFECT CIRCLE TECHNIQUE. THE SAME DRILL BIT WAS USED TO INSERT TWO (2) LOCKING SCREWS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVE RADIOGRAPHS WERE USED TO CONFIRM THE SAME. THERE WAS NO SURGICAL DELAY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. IT WAS REPORTED THAT THE AIMING ARM AND GUIDE WIRE WORKED FINE WHEN USED IN PRIOR SURGERIES. CONCOMITANT DEVICES REPORTED: 10 MM TI HINDFOOT ARTHRODESIS CANNULATED NAIL (PART# 04.008.066S, LOT# 7423633, QUANTITY 1). THIS COMPLAINT IS FOR THREE (3) DEVICES. (B)(4). THIS REPORT IS FOR A SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344962 ↗
• MalfunctionMar 16, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN ANKLE ARTHRODESIS PROCEDURE ON (B)(6) 2018, AS THE SURGEON ATTEMPTED TO INSERT TWO (2) LOCKING SCREWS INTO THE NAIL, THERE WAS A MISALIGNMENT ISSUE. THE DRILL BIT WOULD NOT ALIGN WITH THE NAIL. SURGEON DECIDED TO USE PERFECT CIRCLE TECHNIQUE. THE SAME DRILL BIT WAS USED TO INSERT TWO (2) LOCKING SCREWS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVE RADIOGRAPHS WERE USED TO CONFIRM THE SAME. THERE WAS NO SURGICAL DELAY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. IT WAS REPORTED THAT THE AIMING ARM AND GUIDE WIRE WORKED FINE WHEN USED IN PRIOR SURGERIES. CONCOMITANT DEVICES REPORTED: 10 MM TI HINDFOOT ARTHRODESIS CANNULATED NAIL (PART# 04.008.066S, LOT# 7423633, QUANTITY 1). THIS COMPLAINT IS FOR THREE (3) DEVICES. (B)(4). THIS REPORT IS FOR A SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344961 ↗