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 Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable.The manufacturing location is currently not available.(b)(6).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 surgery for a femoral diaphyseal fracture, it was observed that the radiolucent drive device stopped working.According to the report, the event occurred while during the contralateral cortex without any interferences.As a result, the surgery was completed by manual drilling which resulted in a ten minute delay in the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.It was not reported if there were any 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

Device evaluation update: upon further investigation, it was further determined that the device was not working because the bevel gears were broken and no continues rotation was transmitted.The safety clutch was removed and tested separately and it was determined that it was not blocked and the torque was in range of (1.20-1.50 nm).This part of the investigation was inadvertently omitted from the initial report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as 7/1/2011.The udi has been updated accordingly.The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4) contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.It was further determined that the device failed pretest for check for free movement.It was determined that the device had been heated by repeated use at the power limit and destroyed the bevel gears by heat.It was determined that the observation was an indication of improper handling.The assignable root cause was determined to be due to improper handling which is misuse and/or user error.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: 7227062
• MDR Text Key: 98856159
• Report Number: 8030965-2018-50674
• Device Sequence Number: 1
• Product Code: HWE
• 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,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: 13034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1