MAUDE Adverse Event Report: BIOMET UK LTD. OXF GAP GAUGE MED 1/2MM; KNEE INSTRUMENT

Catalog Number	32-422805
Medical Device Problem Codes	Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: the primary unique device identification (udi) number is not applicable as the device's lot number is unknown.D10: item name: oxf gap gauge med 3/4mm; item number: 32-422806; lot: unknown.Item name: oxf tib template d rt medial; item number: 32-422857 lot: unknown.Item name: oxf tib template c rt medial; item number: 32-422855 lot: unknown.G2 ¿ foreign ¿ france.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 during an initial knee surgery, while testing different polyethylene (pe) thicknesses, repeated use of the thickness gauge against the internal tibial test gauge generated plastic debris.All debris was successfully retrieved from the joint with no harm to the patient or delay to the procedure.The surgical technique was properly followed.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1-h4, h6, h11.The products involved in the reported event were returned for investigation in addition to photographs provided at the time of the complaint.Review of the photographs shows blue material caught in the holes of one the tibial templates along with a picture of the gap gauge clearly showing score marks to its bottom surface.Visual assessment of the returned tibial templates identified signs of extensive use with nicks, gouges and confirms that there are burrs in the holes and slots.The two returned gap gauges exhibit signs of repeated use with surface scratches, nicks and gouges that impede the fingernail.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories for the gap gauges identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Review of the complaint histories for the tibial templates found no additional related complaints for these items and the reported part and lot combinations.Based on the available information, the reported event can be confirmed and the cause of the damage seen to the gap gauges is related to the normal wear on the tibial templates used.The tibial templates have been in the field since 2016.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.
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, d4, d9, d10, g3, g6, h2, h10, h11.D10: item name: oxf gap gauge med 3/4mm; item number: 32-422806; lot: zb170401.Item name: oxf tib template d rt medial; item number: 32-422857 lot: zb161101.Item name: oxf tib template c rt medial; item number: 32-422855 lot: zb160901.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.

• Brand Name: OXF GAP GAUGE MED 1/2MM
• 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: 22166071
• Report Number: 3002806535-2025-00226
• Device Sequence Number: 15755411
• Product Code: LXH
• UDI-Device Identifier: 00880304525436
• UDI-Public: (01)00880304525436(10)ZB170201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 08/08/2025

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: 32-422805
• Device Lot Number: ZB170201
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 08/07/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/04/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2017
• 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