MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD; INSTRUMENT, SURGICAL, ORTHOPEDIC

Model Number	00-5927-050-00
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: associated medical product: milling handpiece: catalog#00592704000, lot#ni.G2: foreign: australia.Diligence is in progress to determine whether the product is available to be returned to zimmer biomet for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial knee procedure, the milling burr was unable to fully assemble with the burr tip, as if something was blocking it from seating.The surgery was able to be completed with a second burr.There was a ten (10) minute surgical delay however no patient impact or adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.This complaint is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• 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: 16902626
• Report Number: 0001822565-2023-01273
• Device Sequence Number: 12467268
• Product Code: HWE
• UDI-Device Identifier: 00889024206144
• UDI-Public: (01)00889024206144(17)250228(10)64655814
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 00-5927-050-00
• Device Catalogue Number: 00592705000
• Device Lot Number: 64655814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 07/12/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/05/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female