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	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the partial left knee arthroplasty that the instrument fractured.No piece fell nor remain into the patient body.All pieces were found.No impact or injury to patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Associated products: item reference: (b)(4), item name: oxf uni ph3 tib impactor, item lot: zb7117655.Foreign- canada.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00180.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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.Visual inspection shows the item and lot numbers match the complaint.Product was not returned in its original packaging and there were missing parts.Device showed wear and damage and the tip was missing on the device.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review of the raw material certificates confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.With the available information, 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 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: 17069671
• Report Number: 3002806535-2023-00181
• Device Sequence Number: 6105090
• Product Code: LXH
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)191104(10)ZB130404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/11/2023

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: ZB130404
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2019
• 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: Reuse
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose