MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 TIB IMPACTOR; KNEE INSTRUMENT

Model Number	32-420932
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 - foreign: canada.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 a left partial knee arthroplasty the impactor fractured and the fractured piece fell to the ground.The patient did not retain any foreign body.The instrument was still usable so the surgeon was able to finish the surgery.No consequences or impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified signs of wear and tear with scratches and gouges.The knob has fractured off from the handle and some of the threads from the knob remain in the handle.Reference attached photographs.The returned device was reviewed with optical microscopy (keyence vhx-2000) and scanning electron microscopy (jeol 6610lv).Optical images of the device are provided in figures 1 ¿ 2, with sem images of the fracture surface provided in figures 3 ¿ 9.Quasi-cleavage overload artifacts were observed throughout the fracture surface, suggesting the overload failure mode.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.As no product was returned, visual and dimensional evaluations of the product could not be performed physically.Visual examination of the provided picture confirms the reported event, the locking screw head has fractured off the thread.Medical records were not provided.A review of the device manufacturing records confirmed no abnormalities or deviations.With the available information, 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.

• Brand Name: OXF UNI PH3 TIB IMPACTOR
• 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: 16894020
• Report Number: 3002806535-2023-00132
• Device Sequence Number: 6141341
• Product Code: LXH
• UDI-Device Identifier: 05019279905638
• UDI-Public: (01)05019279905638(11)181012(10)ZB180803
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/10/2023

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: 32-420932
• Device Catalogue Number: 32-420932
• Device Lot Number: ZB180803
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 08/09/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/30/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2018
• 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: Female