MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; ORTHOPAEDIC IMPLANT IMPACTOR

Model Number N/A

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (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 instrument broke during surgery.Broken instrument caused a surgical time delay of 30 min: broken metal part was searched by x-rax machine however, no sign of metal in patient observed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h4, h6, h10.G3: report source, foreign - event occurred in switzerland.The event reports that the instrument has fractured.This event occurred during surgery.A non-clinically significant (minor, <30mins) delay to surgery was reported.No material remains in the patient.-the complaint has been confirmed following review of the returned instrument, which confirmed the instrument is fractured.The l-shaped posterior hooking foot, which is used to hold the tibial tray during insertion and impaction, has fractured from the main body of the instrument.-a review of the device history records did not identify any discrepancies that would have contributed to the reported event.-a complaint history review identified 41 similar complaints for the same item number, including (b)(4).-a complaint history review identified no similar complaints for the same lot number.-the reported event is covered by cemented oxford partial knee system ¿ risk management report and cemented oxford partial knee system implant i/o table.The severity of the reported event is in line with this risk file.The occurrence rate for all similar events are also in line with the risk file.The rpn is between low risk and medium risk.- this device is used for treatment.-the reported event is not related to a combination of products; therefore, a compatibility review is not applicable.-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 bone.The reusable instrument lifespan manual instructs to look for fractures and surface damage during reprocessing.- the likely condition of the device when it left zimmer biomet is conforming to specification.-the root cause of the reported event could not be determined.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.Corrective and preventive actions: -health hazard evaluation hhe-2019-00134 has been raised to assess the risk of these instruments fracturing within the field.-this hhe resulted in no field safety corrective action.-there has been no higher severity event presented since this hhe was concluded, and the occurrence and risk remains within acceptable limits.No corrective action has been initiated at this time.Risk assessment and occurrence: date: jul 2015 to jun 2020: a) item numbers: all implants compatible with instrument 32-422097 -number of items sold: (b)(4) complaint history search criteria: -date: 01 july 2015 to 29 july 2020 (date search was conducted) -item number ¿ 32-422097 -filters ¿ all complaint categories relating to fracture of the posterior hooking foot c)number of similar complaints identified (excluded (b)(4): 40 -these complaints were then broken down according to the harm of each complaint, as recorded in the rmf: no harm:19 exposure to anaesthesia, minor:12 pain or ache, moderate:8 bone fracture:1 occurrence ratio: -the occurrence ratio has been calculated for each harm: -no harm ¿ 19:108,230 = 1:5696 this gives an occurrence score of 3 -exposure to anaesthesia, minor ¿ 12: 108,230 = 1:9019 this gives an occurrence score of 3 -pain or ache, moderate ¿ 8: 108,230 = 1:12,529 this gives an occurrence score of 2 -bone fracture - 1: 108,230 this gives an occurrence score of 1 risk score the risk score has been calculated for each harm: -no harm: low -exposure to anaesthesia, minor: low -pain or ache, moderate: medium -bone fracture: low if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the instrument broke during surgery.Broken instrument caused a surgical time delay of 30 min: broken metal part was searched by x-rax machine however, no sign of metal in patient observed.

• Brand Name: OXF CMNTLS IMPLANT INSERT
• Type of Device: ORTHOPAEDIC IMPLANT IMPACTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10263013
• MDR Text Key: 198507704
• Report Number: 3002806535-2020-00317
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00080304525672
• UDI-Public: 0080304525672
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB151102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1