MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RADIOLUCENT-DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Concomitant med products and therapy dates: drill bit device (9/30/2020).Reporter's phone number was not provided.The manufacturing location was unknown.Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).Please note that the involved drill bit device has been captured under (b)(4).

Event Description

It was reported from (b)(6) that during an open reduction internal fixation (orif) surgical procedure for a femoral shaft fracture, it was observed that during distal drilling, the drill bit device broke while being used with a radiolucent drive device and a fragment of the drill bit remained in the patient.It was reported that the user could not remove the fragment and the incision was closed with the fragment remaining in the patient.The reporter stated that the radiolucent drive device has an undetermined problem.It was reported that the procedure was completed within a 30-minute delay.There were no reports of prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.G1-2, h4: the date of manufacture and manufacture site name and address were documented as unknown in the initial report.The date of manufacture and manufacture site name and address have all been updated accordingly.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Correction: d10: the date returned to manufacturer was documented as october 28, 2020 on the initial report.This date has been updated to october 29, 2020.If additional information should become available, a supplemental medwatch report will be submitted accordingly.This device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all pretests and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.

• Brand Name: RADIOLUCENT-DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10733399
• MDR Text Key: 213020434
• Report Number: 8030965-2020-08136
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819036307
• UDI-Public: 7611819036307
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention