MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE FORCEPS; INSTRUMENT, EXTREMITIES

Catalog Number 406236

Device Problem Fracture (1260)

Patient Problems Osteopenia/ Osteoporosis (2651); No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code -phx.Concomitant medical devices: part# 405883; lot# 766920; part# 405889; lot# 632440; part# 405800; lot# 671610; part# 115310; lot# 294360; part# 010000589; lot# 661760; part# 113628; lot# 64411951; part# 110031418; lot# 64653405; part# 110031399; lot# 64841368; part# 180552; lot# 154390; part# 180550; lot# 700090; part# 180550; lot# 700090; part# 180552; lot# 096430; part# 115395; lot# 026820.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 approximately two and a half (2.5) weeks ago, the tip of the instrument was discovered to be broken off.It is unknown when the fracturing of the device occurred and the procedure was still completed with the same device.The reporter stated that the surgeon did not note in the op report or see in the images that the piece was retained by the patient.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A glenosphere forceps were returned for evaluation.Visual examination of the returned product identified the device to be fractured.The device has 10 years of field service age and shows multiple signs of usage.Radiographs were provided and reviewed by a health care professional.Review of the available records identified no metallic foreign items.Patient shows signs of mild osteopenia.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GLENOSPHERE FORCEPS
• Type of Device: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10934572
• MDR Text Key: 219545575
• Report Number: 0001825034-2020-04244
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 406236
• Device Lot Number: 248080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 55 YR