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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (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.

Event Description

It was reported during surgery the plastic padding broke off and detached from the instrument.Instrument was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product confirmed that one of the pads had been disassembled.The screw that holds the pad has backed out and can be screwed in and out of the hole.There is no damage to the screw or the pad.The device shows strike marks, nicks, gouges and scratches on the handle which are consistent with wear on the device from repeated use.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was attributed to wear and tear on the device.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: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8568854
• MDR Text Key: 143688992
• Report Number: 0001825034-2019-01961
• 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: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 922860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1