MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD GAP GAUGE LGE 5/6MM; KNEE INSTRUMENT

Catalog Number	32-422812
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10 - associated medical instrument: oxf gap gauge lge 3/4mm; item# 32-422811; lot# zb150901.G2: denmark.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that small grey plastic shavings were discovered while the instruments were being packed after surgery.It is therefore unknown whether any of the shavings may have entered the surgical wound.There have been no reported consequences or impact to the patient.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.Visual examination of the returned oxf gap gauge lge 5/6mm ref (b)(4) lot 150601 identified signs of use (scratches, gouges) but no shavings returned or found.The oxf gap gauge lge 3/4mm ref (b)(4) lot 150901 was not returned for investigation, however pictures of a product ref (b)(4) were provided and identified scratches on the instrument.The lot number is not visible on the pictures.A review of the device manufacturing records of product batch 150601 confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records of product batch 150901 confirmed no abnormalities or deviations.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.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 is available at the time of this report.

• Brand Name: OXFORD GAP GAUGE LGE 5/6MM
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23401029
• Report Number: 3002806535-2025-00516
• Device Sequence Number: 18687002
• Product Code: LXH
• UDI-Device Identifier: 00880304525641
• UDI-Public: (01)00880304525641(10)ZB150601
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 04/09/2026

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: 32-422812
• Device Lot Number: ZB150601
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown