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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 that the impactor broke upon impaction.It was noted that no product fell into the patient.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated.Visual inspection of the item exhibits signs of repeated use (nicked or gouged) and the impactor pad has fractured.All pieces were returned.Dhr was reviewed and no discrepancies relevant to the reported event were found.As the instrument had been in the field for over 13 years, and the signs of repeated use, the root cause can be attributed to the wear and aging of the instrument.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: DRIVER IMPACTOR-FEMORAL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8628699
• MDR Text Key: 145670614
• Report Number: 0001822565-2019-02092
• Device Sequence Number: 1
• Product Code: HWR
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

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: 60284341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1