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

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Foreign: (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.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

It was reported that during an initial knee surgery; the surgeon could not tighten the screw to the fitting guide.Subsequently, another device was used to complete surgery.No adverse events have been reported as a result of the malfunction.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.Visual examination of the returned product identified the tines were slightly bent and the lock nut had been forced over the capture pin.Nicks and gouges indicative of use were also noted.The device history records were reviewed and no discrepancies were identified.A corrective and preventative action investigation into this issue determined 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 made.Therefore, the root cause is attributed to a design issue.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.

• Brand Name: ADJUSTABLE VALGUS ALIGNMENT GUIDE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8226130
• MDR Text Key: 132359780
• Report Number: 0001822565-2019-00040
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: 62861516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1