MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES; KNEE INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during surgery that the pin got stuck in drill hole and fractured.Subsequently, the procedure was completed with another device.No known adverse event was reported.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Visual examination exhibits signs of repeated use (nicked, gouged, burrs).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00511.

Event Description

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

• Brand Name: TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8574624
• MDR Text Key: 143877261
• Report Number: 0001822565-2019-01839
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: 63735849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1