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

Model Number N/A

Device Problem Disassembly (1168)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the device was found by the scrub tech disassembled in pieces.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Concomitant medical products- adjustable valgus alignment guide catalog#: 42509900400 lot#: 62534170.The complaint is considered confirmed as the disassembled parts were returned.The guide was returned and examination of the returned instrument determined that the instrument exhibits signs of repeated use (nicked or scratched).There was no damaged to the knob and thread of the instrument and part was re-assembled with no problems.Dhr was reviewed and no discrepancies were found.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Disassembled parts were returned which were assembled with no issue.However, it could not be determined that disassembly occurred due to misuse or regular wear.Therefore, a definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00318.

Event Description

It was reported that the device was found by the scrub tech disassembled in pieces.Another tray was opened to successfully complete the case.There was no patient harm nor involvement in this malfunction.

Manufacturer Narrative

Upon further review it was found that this malfunction has not been previously reported as causing or contributing to an adverse event.Therefore, the initial report was filed in error and 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: PERSONA ADJUSTABLE VALGUS ALIGNMENT GUIDE
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7193872
• MDR Text Key: 97501269
• Report Number: 0001822565-2018-00317
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• 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: 62376588
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2013
• 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