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 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The reporter¿s complete address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 a femoral diaphyseal fracture surgery, it was observed that the radiolucent drive device stopped working while the surgeon was drilling at the distal end of the femur.According to the surgeon, the drill did not hit the nail and the quality of the patient's bone was good.There was a delay in the surgical procedure; however, the exact duration of the delay was not specified.It was not reported if a spare device was available for use.It was reported that the surgery was completed successfully.There was patient involvement reported.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

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 not confirmed.A functional assessment was performed and the device passed all tests and no failures were identified.The device worked according to the specifications.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6103142161
• MDR Report Key: 7295278
• MDR Text Key: 100906778
• Report Number: 8030965-2018-51349
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819036307
• UDI-Public: (01)7611819036307(11)170307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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 Catalogue Number: 511.300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/25/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR