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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 during surgery, the blue tab broke off the insert impactor.No delay in surgery.Instrument used 1-5 times.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.G3: report source, foreign - event occurred in germany.Summary: the event reports that the cushion pad became loose and fell off.This event occurred during surgery.No further harm was reported.The complaint has been confirmed following review of the returned instrument, which confirms the cushion pad is missing.The instrument should have a total of two cushion pads assembled, but only one cushion pad is present.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 33 similar complaints for the same item number since the instrument was released, with 7 received in the past 3 years.A complaint history review identified one similar complaint for the same item/lot combination.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 likely cause of the reported event is the cushion pads were removed for cleaning/sterilisation (as required) and were not reassembled correctly.No corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm beyond extension to surgery time, minor, has been reported.The item was distributed conforming.Risk assessment: 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 low risk.Sales data: date: july 2017 to june 2020 (most up to date sales data) number of items sold, including all implants compatible with instrument 32-422097: (b)(4).Occurrence ratio: the occurrence ratio has been calculated for each harm: no harm ¿ (b)(4).Exposure to anaesthesia, (b)(4).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 during surgery, the blue tab broke off the insert impactor.No delay in surgery.Instrument used 1-5 times.

• Brand Name: OXF CMNTLS IMPLANT INSERT IMPACTOR
• Type of Device: ORTHOPAEDIC IMPLANT IMPACTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10200167
• MDR Text Key: 197816701
• Report Number: 3002806535-2020-00295
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

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: ZB140701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1