MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD GAP GAUGE MED 1/2MM; 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	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic paddles are leaving blue debris.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 no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 ¿ 32-422806, lot# zb140801, oxf gap gauge med 3/4mm.32-422807, lot# zb140801, oxf gap gauge med 5/6mm.32-422808, lot# zb140801, oxf gap gauge med 7/8mm.32-422809, lot# zb140901, oxf gap gauge med 9mm.G2 ¿ foreign ¿ australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned provided pictures identified signs of instrument wear, light scratches and gouging which could be expected with repeated use and time in the field (approximately ten years).There are some signs of what appears to be faded areas, however due to the quality of the photographs it cannot be determined if this is staining, delamination or another issue.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 identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Based on the available information, the reported event cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD GAP GAUGE MED 1/2MM
• 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: 19517779
• Report Number: 3002806535-2024-00217
• Device Sequence Number: 8540752
• Product Code: LXH
• UDI-Device Identifier: 00880304525436
• UDI-Public: (01)00880304525436(11)140929(10)ZB140801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/29/2024

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: 32-422805
• Device Lot Number: ZB140801
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SE H11 NARRATIVE
• Patient Sex: Unknown