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

Catalog Number	32-422097
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting cementless tibia, metal attachment on inserter snapped.The surgeon was able to retrieve fractured piece.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ united kingdom.D4 - primary device identification (udi) number is not applicable as the lot number of the device is unknown.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.
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, d4, g3, g6, h1, h2, h4, h8, h11.The following section was corrected: h5.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
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: d4, h4.Visually verified item and lot combination.Product exhibits signs of use (scuffs, dings) and confirming complaint - the inserter foot is fractured, all pieces were not returned.Performed dimensional analysis, results are within specification.A review of the device manufacturing records confirmed no abnormalities or deviations.Due to insufficient product information, the compatibility of the involved products could not be verified.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Based on the available information, the reported event can be confirmed.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.Show less.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD CMNTLS IMPLANT INSERT
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21662899
• Report Number: 3002806535-2025-00125
• Device Sequence Number: 8737299
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)131201(10)ZB130901
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 08/20/2025

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 Catalogue Number: 32-422097
• Device Lot Number: ZB130901
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 08/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/10/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown