MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ADJUSTABLE VALGUS ALIGNMENT GUIDE; INSTRUMENT, KNEE

Model Number N/A

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported instrument was supplied in a loan kit tray, arrived at the hospital broken.The wingnut on the adjustable guide was unable to be adjusted, and the inner thread had been bent which resulted in the alignment rod not being able to be passed through the central hole.No patient involvement was reported.

Manufacturer Narrative

(b)(4).G2: australia.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 available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  visual examination of the returned product identified signs of repeated use.The nut component has been forced over the capture pin component, the device has seized and bent the tines on the lock ring shaft.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Medical records were not provided.The issue of the persona valgus guide seizing was previously investigated.The investigation identified that the lock nut mechanism was susceptible to forcible disassembly leading to the device seizing on or not accepting the im rod.A design update was implemented.This device was manufactured by the supplier prior to the design change.Complaint is confirmed through the returned device.The root cause of the reported issue is attributed to a design issue.Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.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.

• Brand Name: ADJUSTABLE VALGUS ALIGNMENT GUIDE
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17429507
• MDR Text Key: 320089966
• Report Number: 0001822565-2023-02013
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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: 42509900400
• Device Lot Number: 62855998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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