MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; SHOULDER, PROSTHESIS

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the surgeon was using the mini baseplate impactor to impact the mini baseplate.When smacking the strike plate a few times, and the plate disengaged from the base.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was visually examined.The instrument shows signs of wear and the strike plate is fractured at the start of the threads.The complaint is confirmed.The device was submitted for fracture analysis to determine failure mode.The analysis determined that the fracture artifacts suggest a possible bending overload.Dhr was reviewed and no discrepancies were found.Root cause is determined to be design deficiency 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: 25MM COMP RVS GLEN TRAY IMPTR
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7346978
• MDR Text Key: 102732307
• Report Number: 0001825034-2018-01983
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK120121
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 405809
• Device Lot Number: 3417413
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1