MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL INSERTER/EXTRACTOR; HIP INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified 2 pieces of the plastic grip to be fractured.Nicks and scratches are present on the shaft.Impact marks are visible on the strike plate.The threaded tip exhibits damage to the threads and foreign debris inside them.Review of the deviation history search identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during washing, the instrument was found to be broken.There was no impact to a procedure and no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNIVERSAL INSERTER/EXTRACTOR
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15817346
• MDR Text Key: 307790481
• Report Number: 0001825034-2022-02618
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-473601
• Device Lot Number: 826540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1