MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 2 PRING INSERTER/IMPACTOR; TRAUMA, INSTRUMENT

Catalog Number 405900

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (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 mdr will be submitted.Product not returned.

Event Description

It was reported that the instrument fractured during the procedure.There was no delay or impact to 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

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the black plastic impactor had fractured.There was impact damage to the strike plate and wear to the shaft of the device.Device history record was reviewed and no discrepancies were found.Root cause could not 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

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

• Brand Name: GLENOSPHERE 2 PRING INSERTER/IMPACTOR
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9085952
• MDR Text Key: 195107470
• Report Number: 0001825034-2019-04077
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405900
• Device Lot Number: 664370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1