MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 4-IN-1 ANTERIOR REFERENCING CUT GUIDE SIZE 4; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant devices: nexgen headless trocar drill pin 3.2mm diameter 75mm length, catalog #: 00590102000, lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2021-00103.
Event or Problem Description
It is reported that the drill pin became jammed within the cutting guide during knee arthroplasty.The disposable pin had reportedly been used multiple times prior to this incident.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned guide showed signs of repeated use and the headless trocar drill pin was seized in one of the guide holes while the other guide hole was found to have scratches and burrs.The pin was identified to have signs of repeated use and the hex feature had fractured off.Dimensional analysis of the products determined that it was conforming to print specifications where measured.The device history records were reviewed and no discrepancies were identified.Per the instructions for use, reuse of a single use device that has come into contact with blood, bone, tissue or other bodily fluids may lead to patient or user injury.Risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.However, 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA 4-IN-1 ANTERIOR REFERENCING CUT GUIDE SIZE 4
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11150866
• Report Number: 0001822565-2021-00104
• Device Sequence Number: 11584677
• Product Code: JWH
• UDI-Device Identifier: 00889024232754
• UDI-Public: (01)00889024232754(10)64327056
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42509908556
• Device Lot Number: 64327056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1