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NA 03.405.000SRecalls & reported problems

Synthes GmbH · RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982300829), received between Jan 14, 2021 and Oct 27, 2022 — classified as 2 malfunctions.

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

Recalls naming this device

  1. Apr 7, 2022Open, Classified

    DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

    Z-1072-2022 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionOct 27, 2022Break; Break

    IT WAS REPORTED ON AN UNKNOWN DATE, DURING POST OP INSPECTION, IT WAS FOUND THAT: 1) DHS COUPLING SCREW WAS BENT FROM USAGE. 2) PLASTIC HANDLE BROKE OFF AS WELL DURING RADIAL HEAD PLANNING. 3) CUTTERS WERE NOT ABLE TO CUT. 4) DRILL GUIDES¿ THREADS WERE STRIPPED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15679224 ↗
  • MalfunctionJan 14, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2020 WHILE DOING A RADIAL HEAD REPLACEMENT, AFTER USING THE PALNER, IT WAS DISCOVERED THAT SMALL PIECES OF WHITE PLASTIC HAD COME OFF DURING THE PLANNING PROCESS. ALL OF THE NOTICEABLE PIECES WERE REMOVED AND THE AREA WAS IRRIGATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE OF SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11170302 ↗

Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices

All PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.