MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNCEMENTED TIBIAL IMPACTOR; OXFORD UNCEMENTED KNEE SYSTEM INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cmp-(b)(4).Foreign - united kingdom.Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.
Event or Problem Description
It was reported that during the implantation, a small part of the instrument broke off inside the patient.This was only discovered in a post-op x-ray.The patient was returned to theatre and the surgeon removed the remnants of the instrument.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the hook had broken from the body of the instrument.There is an additional picture of the broken piece which was retrieved from the patient.The event can be confirmed from the pictures.Review of the device history records identified no deviations or anomalies during manufacturing.Post-operative radiographs revealed metal foreign body in posterior knee soft tissue.Initial attempt at arthroscopy but unable to visualise foreign body in posteromedial compartment.Small medial incision and blunt dissection to posterior capsule.Foreign body identified and retrieved via anterior knee incision opening up the original approach.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD UNCEMENTED TIBIAL IMPACTOR
• Common Device Name: OXFORD UNCEMENTED KNEE SYSTEM 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: 15238961
• Report Number: 3002806535-2022-00356
• Device Sequence Number: 12373720
• Product Code: HRY
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)160808(10)ZB160808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB160808
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female