MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; BMET GENERAL KNEE INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being 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: when they took out the poly with the « this side up » device in the oxford instruments, the trial poly cracked on the bottom side.It cannot be desterilized.Patient outcome - no further information.
Event or Problem Description
It was reported, that: when they took out the poly with the « this side up » device in the oxford instruments, the trial poly cracked on the bottom side.It cannot be sterilized.Patient outcome: no further information.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, and h10.Complaint summary: adequate photographs have not been provided and the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history identified 8 additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.Medical records or x-rays have not been provided as there was no patient harm.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.It has been confirmed that the instrument is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h1, h2, h3, h4, h6, h10.Visual examination of the returned product identified the bearing was intact with a partial fracture on one corner.The bearing also showed general wear and tear.The bearing has potentially been in the field for 3 years and 8 months.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM
• Common Device Name: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13024656
• Report Number: 3002806535-2021-00530
• Device Sequence Number: 4848473
• Product Code: NRA
• UDI-Device Identifier: 05019279346813
• UDI-Public: (01)05019279346813(11)180720(10)ZB180505
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

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: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB180505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 04/25/2022; 10/20/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 04/26/2022; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• 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
• 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
• Patient Sex: Unknown