MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSADIAL HEAD IMPACTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Complaint sample was evaluated and the reported event was confirmed.The impactor was returned for evaluation.As returned, the threads on the strike plate and the impactor tip fractured.Dhr 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.

Event Description

It was reported that at the beginning of a right total shoulder arthroplasty, the distal part of the impactor was stripped.Another impactor was used to complete the surgery.There was no injury to the patient.The impactor did not come in contact with the patient.

• Brand Name: VERSADIAL HEAD IMPACTOR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7575013
• MDR Text Key: 110359968
• Report Number: 0001825034-2018-03818
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 407297
• Device Lot Number: 046230
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1