MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TRIAL BRNG LRG SZ 4/5; 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	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products:: 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 the poly trial bearing cracked and is loose.
Event or Problem Description
It was reported that the poly trial bearing cracked and is loose.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The devise is used for treatment.Review of returned product confirms the reported event.Visual inspection of the returned instrument shows that the 4mm trial bearing has fractured at the point where the handle fits the trial bearing.General wear & tear is evident and is expected due to repeated use during its time in the field (approximately 4 years and 6 months).Dimensional check was not carried out as dimensional non-conformance does not have any impact on the reported event.No assembly checks were carried out as returned product was damaged.A review of the raw material certificates (item# 32-420382-00 lot# 148883 rir) from ensinger confirms that the material used to produce the instruments were conforming to standards and specification prior to shipment to zb.A review of the manufacturing history record (item# 32-420382 lot# 497520 dhr) shows that all parts were manufactured and verified as conforming to specification and quality characteristics as defined by zimmer biomet.The product item no.32-420382 batch 497520 has not been involved in any previous field actions the root cause cannot be determined with the available information however, the likely root cause of the reported event is damage caused by repeated use during repeated use and time spent in the field (approximately 4 years and 6 months) or damage during reprocessing.No corrective actions are required at this time.

• Brand Name: OXFORD TRIAL BRNG LRG SZ 4/5
• 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: 12826547
• Report Number: 3002806535-2021-00499
• Device Sequence Number: 3951571
• Product Code: JWH
• UDI-Device Identifier: 05019279483891
• UDI-Public: 05019279483891
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 32-420382
• Device Lot Number: 497520
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2017
• 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