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

Catalog Number 511.300

Device Problems Device Emits Odor (1425); Mechanical Jam (2983); Mechanics Altered (2984)

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

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

This is report 1 of 2 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the drill bit device started showing abnormal spinning and the smell of something burning came from the radiolucent drive device.The reporter stated that when the connection between the two devices was checked, the surgeon found that both parts were stuck together and did not come off.There was a ten minute delay in the surgical procedure.It was reported that the surgeon eventually completed the drilling by freehand.There was patient involvement reported.There were no adverse consequences 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

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.Serial number and device manufacture date: the device serial number was not provided by the reporter in the initial report.Therefore, the serial number and manufacture date was documented as unknown.Upon receipt of the device, the serial number was identified as (b)(4).The device manufacture date is apr 26, 2011.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the drill bit device was deformed and coated with bush abrasion residue of the radiolucent drive device.It was further determined that the deformation of the two devices was a result of high friction between the radiolucent drive device and the drill bit device.It was further observed that the coupling tool side was worn out.Therefore, the reported condition was confirmed.The assignable root cause could not be fully determined, however, the failure was most likely due to a result of excessive use/handling error, which is user error, misuse, and / or abuse.If information is obtained that was not available, 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 POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5703945
• MDR Text Key: 48011193
• Report Number: 8030965-2016-13877
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• 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/I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1