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 Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The reporter¿s complete address was not provided.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an open reduction internal fixation (orif) surgery for a femoral diaphyseal fracture, it was discovered that when the electric pen drive device touched the nail while drilling at the distal hole, it stopped working.It was further reported that the insertion angle was changed and the surgeon tried to use the device from the beginning; however, the device did not work.It was reported that another drill device was used to successfully insert the screw through the far end.There was less than a 30 minute delay to the surgical procedure.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: d10: the date device returned to manufacturer was documented as 3/14/2018 on the initial report.It has been updated as 3/13/2018.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.During pre-repair diagnostic assessment testing, it was determined that testing failed and could not be performed due to broken and defective bevel gears.It was observed that the gear was broken and torn off.It was determined that whenever the nail was hit, the drill bit angle needed to corrected before the drilling started again.It was determined that the bevel gears were most probably defective due to normal wear.However, it could not be excluded that the device was handled improperly or it was very often in use.The assignable root cause was determined to be due wear from normal use servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 7365857
• MDR Text Key: 103311175
• Report Number: 8030965-2018-52344
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819036307
• UDI-Public: (01)7611819036307(11)150410
• Combination Product (y/n): N
• PMA/PMN Number: K971544
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1