MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the tip of the inserter fractured during surgery.No harm to patient was reported.No further outcome.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: photographs of the instrument have been provided which confirms the foot has fractured from the instrument.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified additional similar complaints (52) for the reported item number, and zero additional complaints for the same item/lot combination.This device is used for treatment.The issue relates to an instrument therefore an implants compatibility check is not required.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event cannot be determined with the information provided.The fracture could be ascribed to expected wear and tear over time, over impaction of the instrument, over/under-tightening of the instrument against tibial trays, sub-optimal use during surgery, or a combination of all these factors.The ifu provided with the compatible implants states: intra-operative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture.Surgical instruments should only be used for their intended purpose.Biomet recommends that all instruments be regularly inspected for wear and disfigurement, and prior to surgery.The surgical technique for cementless implantation advises that the device is to be impacted by the toffee mallet and that the device is to release the tibial tray before the tray is fully seated within the patient¿s bone.The reusable instrument lifespan manual instructs to look for fractures and surface damage during reprocessing.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text: item not returned.

Event Description

It was reported that the tip of the inserter fractured during surgery.No harm to patient was reported.No further outcome.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Visual examination of the returned product confirms the adjustable foot has fractured.The fractured piece was not returned with the product.The instrument exhibits indentations on the top of the main body suggesting excessive use during insertion/impaction.There is also evidence of indentations on the back side of the instrument suggesting use in the anterior to posterior direction.Review of the device history record identified no deviations or anomalies during manufacturing.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: OXF CMNTLS IMPLANT INSERT
• Type of Device: BMET GENERAL KNEE 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: 12877886
• MDR Text Key: 282559403
• Report Number: 3002806535-2021-00511
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)100709(10)ZB091224
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB091224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1