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

Catalog Number 511.300

Device Problems Overheating of Device (1437); Device Inoperable (1663); Noise, Audible (3273)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

Reporter's complete address and phone number were not provided.The serial number was unknown; therefore, the date of manufacture was unknown.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 unspecified surgical procedure for a humerus diaphysis fracture, it was observed that the radiolucent drive stopped working completely and made an abnormal noise at the time of drilling at the second proximal hole of an expert humeral nail long which retrograded after being inserted.According to the reporter, the surgeon removed a screw and then tested if the device would spin without being loaded but it did not work.It was further reported that the surgeon gave up using the device as the joint part of the device heated up.It was further reported that as the cortex at the near end was already penetrated, the surgeon carefully drilled the cortex at the far end by hand while using a drill tip.As a result, the surgery was delayed for five minutes.It was unknown if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The initial report stated that the date of manufacture was unknown because the serial number was unavailable, the date of manufacture was not unknown, it was reported as may 04, 2015.The serial number was reported as unknown in the initial report.The serial number has been updated to (b)(4).The udi has been updated accordingly.The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a supplemental medwatch 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
• 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 ; 6107195000
• MDR Report Key: 7212946
• MDR Text Key: 98193538
• Report Number: 8030965-2018-50566
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819036307
• UDI-Public: (01)7611819036307
• 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: 12/25/2017

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: 01/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/25/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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