MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; KNEE INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- foreign - south africa investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that tibia implant inserter tip broke when engaging the implant to the instrument.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.Attempts have been made and all additional information received has been included in this report.
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 and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The product was not returned.Visual examination of the provided picture confirms an inserter with a broken off foot.There does appear to be tarnishing to the surface of the material and rounding to the grub screws indicating that the instrument has been used and re-processed many times.Nothing further can be gained from the photograph regarding the fracture.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.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: OXF CMNTLS IMPLANT INSERT
• Common Device Name: KNEE INSTRUMENT
• 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: 19592541
• Report Number: 3002806535-2024-00230
• Device Sequence Number: 8493824
• Product Code: LXH
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 32-422097
• Device Lot Number: UNKNOWN
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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