MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from the hospital that during surgery, the scrub nurse was preparing final tibial implant on the cementless tibial impactor and while tightening, the little hook broke off.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign event occurred in canada.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that the instrument has fractured.This event occurred during surgery.No further information, including harm, has been provided.The complaint has been confirmed following review of the returned instrument, which confirmed the instrument is fractured.The lshaped 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 40 similar complaints for the same item number.A complaint history review identified two similar complaints for the same lot number.The severity of the reported event is in line with this risk file.The occurrence rate for all similar events is 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 intraoperative 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 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/undertightening of the instrument against tibial trays, suboptimal use during surgery, or a combination of all these factors.Health hazard evaluation (b)(4) 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.Correctie action taken: health hazard evaluation (b)(4) 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.Preventive action taken: no preventive action required at this time.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 from the hospital that during surgery, the scrub nurse was preparing final tibial implant on the cementless tibial impactor and while tightening, the little hook broke off.No piece went missing in patient.No delay of the surgery.

• Brand Name: OXF CMNTLS IMPLANT INSERT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9503299
• MDR Text Key: 196222808
• Report Number: 3002806535-2019-00936
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: ZB150702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1