MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CRUCIATE PUNCH/TRIAL; IMPACTOR

Catalog Number 32-487276

Device Problem Fracture (1260)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported that during kit inspection, two trial instruments were found to be brittle which resulted in a fracture on the wing chisel.There was no patient involvement and no adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: vngd cruciate punch/trial: catalog#32-487276, lot#zb7273405.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2023-01933.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

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection of the returned item found it to exhibit signs of use and was fractured.Device was submitted for further analysis.Analysis determined device experienced bending overload fracture.This complaint is confirmed based on product evaluation.Device history record was reviewed and no discrepancies related to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD CRUCIATE PUNCH/TRIAL
• Type of Device: IMPACTOR
• 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: 17564329
• MDR Text Key: 321406893
• Report Number: 0001825034-2023-01932
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00880304434783
• UDI-Public: (01)00880304434783(11)200327(10)Z19H0983
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-487276
• Device Lot Number: Z19H0983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.