MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLO-FEMORAL JOINT PEG/TAIL DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC

Model Number	00-5927-060-00
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a drill lodged in a guide and became stuck.The tip of the drill bit fractured.There was no patient involvement as the malfunction did not occur during surgery.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: patello-femoral joint peg/tail guide size 2, left: catalog#00592706201, lot#60919555.Multiple mdr reports have been filed for this event; please see associated report: 0001822565-2022-00697.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; h10.H6: proposed component (annex g) code is mechanical (g04) - drill bit.Visual examination of the returned product identified signs of repeated use (nicked / gouged), damaged flutes, fractured and seized in the guide.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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 PEG/TAIL DRILL
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• 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: 13734067
• Report Number: 0001822565-2022-00696
• Device Sequence Number: 20101011
• Product Code: HWE
• UDI-Device Identifier: 00889024206168
• UDI-Public: (01)00889024206168(10)63872350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 00-5927-060-00
• Device Catalogue Number: 00592706000
• Device Lot Number: 63872350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown