NA 04.005.666Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982086907), received between Oct 24, 2018 and Oct 24, 2018 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K970733); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS (B)(6) 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) TI END CAP T25 STRDRV HINDFOOT ARTHRO NAIL-EX SPIRAL BLADE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 4 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002258 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS (B)(6) 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) 6.0MM TI LOCKING SCREW W/T25 STARDRIVE 76MM FOR IM NAILS THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002114 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970733. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2013 · Apr 18, 2013 · Terminated
  Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.