MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CONTROL IMPACTOR; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The complainant 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.

Event Description

It is reported that during kit inspection at the zimmer biomet (b)(6) warehouse, the impactor was identified to be broken.There was no patient involvement.No adverse events were identified as a result of this malfunction.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed.The returned impactor showed signs of repeated use.One of the subcomponents was fractured, resulting in it being disassembled from the impactor assembly.Further analysis determined the fracture was caused by torsional fatigue.An eds semi-quantitative elemental analysis of the impactor showed that it was consistent with 17-4 ph stainless steel.The device history records were reviewed and no discrepancies were identified.The root cause of the reported issue is attributed to wear and tear of the device from repeated use over time.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: VANGUARD CONTROL IMPACTOR
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10922298
• MDR Text Key: 218918755
• Report Number: 0001825034-2020-04166
• Device Sequence Number: 1
• Product Code: HWA
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-486209
• Device Lot Number: ZB091130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1