MAUDE Adverse Event Report: BIOMET UK LTD. OXF TIB IMPACTOR SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

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

When disassembling the driver prior to sterilisation, the screw is broken off.

Manufacturer Narrative

Cmp-(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The event reports that the screw has detached from the instrument.This event was identified when instrument was being sterilised.There is no patient involvement reported.The complaint has been confirmed following review of the returned product provided, which confirmed the screw had fractured.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 4 similar complaints (5 in total) for the same item number.A complaint history review identified no similar complaints for the same lot number.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Risk management file documents the estimated residual risk associated with the reported event.The severity of the reported event is in line with this risk file.The likely condition of the device when it left zimmer biomet is conforming to specification.Failure analyst report has concluded that a brittle fracture occurred and is likely due to wear and tear over repeated usages.Consequently, no corrective action has been initiated at this time.

Event Description

When disassembling the driver prior to sterilisation, the screw is broken off.

• Brand Name: OXF TIB IMPACTOR SCREW
• 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: 9479904
• MDR Text Key: 191453023
• Report Number: 3002806535-2019-00928
• 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: 08/19/2020

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: 32-420932
• Device Lot Number: ZB180702
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1