MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION INTRAMEDULLARY TIBIAL RESECTION CUT GUIDE RIGHT; INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - nexgen headless trocar drill pin 3.2mm catalog #: 00590102000 lot #: ni.The complainant 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.H3 other text : investigation incomplete.

Event Description

It was reported during knee arthroplasty that the pin cold welded in the tibial cut guide and subsequently fractured.As the cut had already been completed, the procedure was not impacted.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned resection guide identified signs of repeated use and scratches.There was also slight burring and striations in the hole where the pin was lodged, however, the pin was not returned.Pictures provided of the pin confirmed it was fractured.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.

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.

• Brand Name: PERSONA REVISION INTRAMEDULLARY TIBIAL RESECTION CUT GUIDE RIGHT
• 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: 17737313
• MDR Text Key: 323290115
• Report Number: 0001822565-2023-02487
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024558878
• UDI-Public: (01)00889024558878(10)65003486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• 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: 12/19/2023

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: 42587000202
• Device Lot Number: 65003486
• 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: 08/21/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/12/2023; 12/15/2023
• Supplement Dates FDA Received: 11/02/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose