MAUDE Adverse Event Report: BIOMET UK LTD. OXF KNEE PH3 I/M ROD RMVL HK; 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 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: 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 im rod removal hook broke when the doctor was trying to remove the im rod.

Event Description

It was reported that: the im rod removal hook broke when the doctor was trying to remove the im rod.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the complaint states, (b)(6) 2021.It was reported that: the im rod removal hook broke when the doctor was trying to remove the im rod.Patient involvement- no further outcome.Event occurred during surgery.No health consequences or impact.Visual inspection confirms that the large pin had fractured flush with the outside diameter of the shaft.The instrument shows signs of wear & which is in line with repeated use, reprocessing and time in field (approximately 5 years).Dimensional check was not carried out as dimensional non-conformance does not have any impact on the reported event.No assembly checks were carried out as returned product was not a part of an assembly.Review of material certificates confirm that the material for the instruments components were conforming to standards and specification prior to shipment to (b)(4).A review of the manufacturing history records and deviation history record shows that there were no recorded non-conformances during the production of the instrument.The certificate of compliance confirms that the device was processed and verified in line with the specification and quality characteristics after rework activity was completed as defined by zimmer biomet.The product item no.32-401111, batch 596400 has not been involved in any previous field actions or capas.No corrective actions are required at this time.The definitive root cause of the reported event could not be determined based on current available information.However, excessive forces being applied, damage due to mishandling or wear and tear caused by repeated use during repeated use and time spent in the field (approximately 5 years) could be contributing factors.The reusable instrument lifespan manual instructs to look for fractures and surface damage during reprocessing.Instructions state, as per reusable instrument lifespan manual: while loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions below.1.Instruments should be inspected for completeness and function.2.Inspection includes: a.Checking instruments that form part of a larger assembly or assemble with mating components.B.Inspecting for all forms of wear outlined in this manual.3.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.4.If the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.The hazard and reported harm are covered by the risk file and the severity risk score is within acceptable limits, however the occurrence risk score has exceeded that stated in the risk file.The overall risk is considered to be low.If any additional information becomes available, then the complaint will be reopened and investigated further.A supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF KNEE PH3 I/M ROD RMVL HK
• 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: 12735620
• MDR Text Key: 279567595
• Report Number: 3002806535-2021-00478
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 05019279469246
• UDI-Public: 05019279469246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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: 32-401111
• Device Lot Number: 596400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• 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