MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI I/M ROD LINK; BMET GENERAL KNEE INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that femoral link device broke inside intramodulary rod during surgery.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: h6.Visual examination of the returned device shows signs of use with scratches on the surface of the device.One of the posts has fractured off the rod link and was not returned.The product has a potential field life of twelve years.As the device has performed over this time without issue, exhibits signs of extensive use over that time, it is not deemed to be a manufacturing or material related and therefore fracture analysis has not been performed.With the available information, a definitive root cause could not 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.
Additional Manufacturer Narrative
(b)(4).D10 - medical device: oxford pks cocr size d lm std; item# 154724; lot# 66338084.Oxford keel bld stk hub; item# 506109; lot# 430955.Oxf twin-peg cmntd fem lg pma; item# 161470; lot# 66058843.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Visual examination of the provided picture does appear to identify that one of the pins is missing and that the instrument appears to exhibit signs of multiple uses due the presence of dents and scratches.As the photo is obscured by what looks like the rod, it is not possible to gain any further information regarding the fracture part.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause could not 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: OXFORD UNI I/M ROD LINK
• 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: 18737034
• Report Number: 3002806535-2024-00065
• Device Sequence Number: 12496164
• Product Code: LXH
• UDI-Device Identifier: 05019279404445
• UDI-Public: (01)05019279404445(11)120210(10)ZB120201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/26/2024

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: 32-422822
• Device Lot Number: ZB120201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 03/13/2024; 04/25/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/07/2024; 04/10/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose