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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that during a partial knee arthroplasty, the drill pin became jammed in the tibial cut guide.The procedure was completed utilizing another device.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).Concomitant devices - nexgen headless trocar drill pin 3.2mm diameter 75mm length catalog #: 00590102000 #: ni.The event was initially reported under the wrong mfr number: 0001822565-2022-01551.The 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned device identified signs of repeated use and the drill pin was seized in one of the guide holes.The device history records were reviewed and no discrepancies 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

His follow-up report is being filed to correct information.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under manufacturing report number 0001822565-2022-01551.

Event Description

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

• Brand Name: TIBIAL CUT GUIDE 5 DEGREES LEFT MEDIAL/RIGHT LATERAL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15121589
• MDR Text Key: 300919744
• Report Number: 0001825034-2022-01732
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024582842
• UDI-Public: (01)00889024582842(10)64687543
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 42539905195
• Device Lot Number: 64687543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose