MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID 4MM TRIAL PT TRIAL PT; EXTREMITIES, INSTRUMENT

Catalog Number 406193

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that during the surgery, while removing the glenoid trial, one of the pegs broke.The broken peg was removed from the patient shoulder.All pieces were found.There had no piece remaining into the patient body.Patient had very hard bone.There was no injury to the patient body/health.

Event Description

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

Manufacturer Narrative

Visual examination of the returned product identified: visual inspection of the returned product confirms one of the pegs has fractured off.All the pieces were returned.Cosmetic inspection could not verify item and lot numbers as it is not etched on the part.Inspection found damages such as nicks, gouges and fractured.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: MD HYBRID GLENOID 4MM TRIAL PT TRIAL PT
• Type of Device: EXTREMITIES, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10697247
• MDR Text Key: 211939902
• Report Number: 0001825034-2020-03847
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 406193
• Device Lot Number: 483840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1