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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.(b)(6).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 initial surgery the tibal inserter damaged, the event occurred after implantation, during procedure.No affect on surgery or patient.

Event Description

It was reported that during initial surgery the tibal inserter damaged, the event occurred after implantation, during procedure.No affect on surgery or patient.Additional information received: the inserter broke at the tip where it holds the definitive implant.This was due to wear and tear of the instrument.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in south africa.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.There are 28 complaints reported with similar issue and hhe2019-00134 has been raised and was completed in september 2019 with no field action required.This issue is also being monitored by complaint trending.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of this complaint could not be determined with the information provided to date.The instrument does not withstand mechanical forces.The details of the reported event do not allege that there was any patient harm.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in rmr attached, which is in line with the risk file.Additionally, hhe-2019-00134 has been completed to asses this issue, and was completed in september 2019 with no field action required.This issue is also being monitored by complaint trending.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• 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: 10377908
• MDR Text Key: 202002633
• Report Number: 3002806535-2020-00366
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB170602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other