MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRIVER IMPACTOR FEMORAL; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received 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 during an initial procedure of unicompartmental knee arthroplasty, the instrument fractured.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the instrument indicates that the head of the impactor indicates signs of repeated use and has 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.

• Brand Name: DRIVER IMPACTOR FEMORAL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7391504
• MDR Text Key: 104278743
• Report Number: 0001822565-2018-01938
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 02/25/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00133602800
• Device Lot Number: 62285912
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 71 YR