MAUDE Adverse Event Report: BIOMET UK LTD. INTRAMEDULLARY ROD LINK; OXFORD MICROPLASTY INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products : intramedullary rod removal hook with t-handle item# 32-401111, lot# unknown.Report source: foreign : germany.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00039.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental 3500a will be submitted.
Event or Problem Description
It was reported that: the hook for removing the im rod broke off during the operation, nothing remained in the patient.No consequences or impact to the patient.At the same time, a tip of the connecting piece broke off during the operation.Nothing remained in the patient and could be removed from the im.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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.Visual examination of the provided pictures identified that the alignment pin has fractured on the oxford knee i/m rod link.Lot identification is necessary for review of device history records, lot identification was not provided.Devices are used for treatment.Medical records were not provided.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.
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 product was returned, and a visual inspection shows the item and lot numbers match the complaint.Both of the returned devices showed wear and damage from use.Fracture analysis was performed on the returned devices, which reported that optical images of the device fracture surface show artefacts such as river lines and a bending hinge, suggesting a bending overload mode of failure.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Upon receipt of the item lot numbers, review of the complaint histories identified no additional similar complaints for the reported part and lot combinations.With the information available, 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: INTRAMEDULLARY ROD LINK
• Common Device Name: OXFORD MICROPLASTY INSTRUMENTS
• 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: 16361020
• Report Number: 3002806535-2023-00040
• Device Sequence Number: 12648368
• Product Code: JWH
• UDI-Device Identifier: 05019279404445
• UDI-Public: (01)05019279404445(11)160109(10)ZB160102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183583
• 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): 03/28/2024

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: 32-422822
• Device Lot Number: ZB160102
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 03/21/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/05/2023; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2016
• 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: Prefer Not To Disclose
• Patient Weight: 90 KG