Inserter Adapter OTD Straight 1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07350137521019), received between Jul 25, 2025 and Jul 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 28, 2025Open, Classified

   Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

   Z-2615-2025 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJul 25, 2025Fracture; Fracture

  A CUSTOMER HAS REPORTED A COMPLAINT REGARDING REF 30-201 INSERTER ADAPTER OTD STRAIGHT. THE ISSUE WAS A WELD BREAKAGE BETWEEN THE PIN AND INSERTER HOLDER OF INSERTER ADAPTER OTD STRAIGHT DURING A SURGICAL PROCEDURE. THE ADAPTERS ARE INTENDED TO BE USED AS A PART OF OTS HIP FOR REAL TIME TRACKING OF INSTRUMENTS RELATIVE TO THE PATIENT´S ANATOMY DURING ORTHOPEDIC SURGERY. THE INSERTER ADAPTERS ARE INTENDED TO BE ATTACHED TO A CUP INSERTER TOOL. THE WELD BREAKAGE OCCURRED WHILE PERFORMING SURGICAL IMPACTIONS USING JOHNSON & JOHNSON MEDTECH EMPHASYS STRAIGHT IMPACTOR (THE CUP INSERTER TOOL), 4812-01-150. THE SURGICAL TEAM NOTICED THE BREAKAGE AND THE PIN COULD BE PULLED OUT. TO PROCEED WITH THE SURGERY, THE TEAM STARTED TO USE A SECOND REF 30-201 INSERTER ADAPTER OTD STRAIGHT (PREPARED AS A BACK-UP ITEM, AVAILABLE IN OR). DURING THE SAME SURGICAL PROCEDURE, THE SECOND ADAPTER FAILED DURING IMPACTIONS, USING THE CUP INSERTER TOOL. ALSO THIS FAILURE CONSISTED OF A WELD BREAKAGE BETWEEN THE PIN AND INSERTER HOLDER. THE SURGICAL PROCEDURE COULD CONTINUE BY REVERTING TO CONVENTIONAL SURGERY. NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION WERE REPORTED. IMAGES WERE PROVIDED T

  Patient problems: Insufficient Information

  MAUDE report 22613203 ↗
• MalfunctionJul 25, 2025Fracture; Fracture

  A CUSTOMER HAS REPORTED A COMPLAINT REGARDING REF 30-201 INSERTER ADAPTER OTD STRAIGHT. THE ISSUE WAS A WELD BREAKAGE BETWEEN THE PIN AND INSERTER HOLDER OF INSERTER ADAPTER OTD STRAIGHT DURING A SURGICAL PROCEDURE. THE ADAPTERS ARE INTENDED TO BE USED AS A PART OF OTS HIP FOR REAL TIME TRACKING OF INSTRUMENTS RELATIVE TO THE PATIENT´S ANATOMY DURING ORTHOPEDIC SURGERY. THE INSERTER ADAPTERS ARE INTENDED TO BE ATTACHED TO A CUP INSERTER TOOL. THE WELD BREAKAGE OCCURRED WHILE PERFORMING SURGICAL IMPACTIONS USING JOHNSON & JOHNSON MEDTECH EMPHASYS STRAIGHT IMPACTOR (THE CUP INSERTER TOOL), 4812-01-150. THE SURGICAL TEAM NOTICED THE BREAKAGE AND THE PIN COULD BE PULLED OUT. TO PROCEED WITH THE SURGERY, THE TEAM STARTED TO USE A SECOND REF 30-201 INSERTER ADAPTER OTD STRAIGHT (PREPARED AS A BACK-UP ITEM, AVAILABLE IN OR). DURING THE SAME SURGICAL PROCEDURE, THE SECOND ADAPTER FAILED DURING IMPACTIONS, USING THE CUP INSERTER TOOL. ALSO THIS FAILURE CONSISTED OF A WELD BREAKAGE BETWEEN THE PIN AND INSERTER HOLDER. THE SURGICAL PROCEDURE COULD CONTINUE BY REVERTING TO CONVENTIONAL SURGERY. NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION WERE REPORTED. IMAGES WERE PROVIDED T

  Patient problems: Insufficient Information

  MAUDE report 22613017 ↗