MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL TIBIAL CUT GUIDE; DEPTH GAUGE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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 device fractured and the pins are deformed which affected the procedure.No known adverse event was reported.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through visual inspection.Both the returned drill pin and cut guide exhibited signs of repeated use, however, the hex feature of the drill pin had fractured off and the cut guide was also discolored.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.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.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, it was reported that this event occurred during surgery.

Manufacturer Narrative

Upon receipt of additional information, this report will be completed under correction manufacturing report number 0001825034-2021-01612.

Event Description

Upon receipt of additional information, this report will be completed under correction manufacturing report number 0001825034-2021-01612.

• Brand Name: PERSONA PARTIAL TIBIAL CUT GUIDE
• Type of Device: DEPTH GAUGE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8797849
• MDR Text Key: 151291926
• Report Number: 0001822565-2019-02984
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 42539905185
• Device Lot Number: 64040326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1