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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown brasseler pfj hand piece.Customer has indicated that the product will not 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.
Event or Problem Description
It was reported that a hand piece would not spin the burr.There is no additional information available.
Additional Manufacturer Narrative
Upon further investigation, it was determined that there was no issue with the pfj milling burr.The reported event is for pfj handpiece malfunction.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon further investigation, it was determined that there was no issue with the pfj milling burr.The reported event is for pfj handpiece malfunction.The initial report was submitted in error and should be voided.

• Brand Name: PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11814275
• Report Number: 0001822565-2021-01319
• Device Sequence Number: 14400999
• Product Code: HWE
• UDI-Device Identifier: 00889024206144
• UDI-Public: (01)00889024206144(17)251012(10)64826506
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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 Expiration Date: 10/12/2025
• Device Model Number: N/A
• Device Catalogue Number: 00592705000
• Device Lot Number: 64826506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10