MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD 4MM DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that a 4mm oxford drill bit broke in half during femur preparation.The procedure was completed using another instrument.No delay was reported.

Event Description

It was reported that a 4mm oxford drill bit broke in half during femur preparation.The procedure was completed using another instrument.No delay was reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, 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.A review of the complaint database over the last 3 years has found 1 complaint for this item code 32-420253.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in cause.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product not returned.

Event Description

It was reported that a 4mm oxford drill bit broke in half during femur preparation.The procedure was completed using another instrument.No delay was reported.

Manufacturer Narrative

(b)(4).This supplemental report is being submitted to relay additional information now that the product has been returned.The complaint has been confirmed following review of the returned instrument and photographs provided, which confirmed the instrument is fractured along the body.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 1 additional complaint (2 complaints in total including the initiating complaint) have been identified in the 3 years prior to the notification date, and no additional complaints were identified 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.Reusable instrument lifespan manual 1219.4-glbl-en-issue date 2021-04-08 mc0000241748 lists surface damage and fracture as an indicator that the device is no longer suitable for use.The likely condition of the device when it left zimmer biomet is conforming to specification.The likely root cause of the reported event is the instrument has surpassed its reusable life (aged).The instrument had been in the field for approximately 14 years before the reported event.During this time it is likely to have been subject to multiple uses and multiple decontamination and sterilisation cycles.No corrective action required at this time.The item was distributed conforming.The instrument has likely passed its reusable lifespan, which is well documented in the reusable instrument lifespan man.

• Brand Name: OXFORD 4MM DRILL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9370065
• MDR Text Key: 217447462
• Report Number: 3002806535-2019-00898
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 32-420253
• Device Lot Number: 741140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female