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 Sticking (1597); Positioning Problem (3009)

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

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The contact¿s phone number was not provided.The manufacturing location was unknown.The lot number was unknown; therefore, the device manufacture date is unknown.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)(4) that during a proximal humerus fracture surgery using a multiloc humeral nail long, it was discovered that the radiolucent drive device got stuck and did not rotate when the surgeon was performing a distal fixture.The reporter stated that the surgeon then checked the device out of the patient's body and the device stopped moving.According to the reporter, the surgeon continued drilling until the device got stuck.The device was then removed and the drilling was completed by hand.The reporter stated that the surgery was completed successfully.There was a thirty minute delay to the surgical procedure.It was not reported if a spare device was available for use.According to the reporter, the patient had a high bone density, and the safety mode might have been on due to interference with the nail.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.No adverse consequences were reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Correction: the device serial number was inadvertently referred to in the initial report and as a lot number.The device has a serial number and not a lot number.(b)(4).Serial number and device manufacture date: the device serial number was unknown the initial report.Therefore, the manufacture date was documented as unknown.Upon receipt of the device the serial number was identified as (b)(4).The device manufacture date has been updated to oct 15, 2010.The manufacturer location was unknown in the initial report.The location has been updated to (b)(4).Contact office name/address has been updated accordingly to reflect the manufacturing facility.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.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.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 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: 5798097
• MDR Text Key: 50621277
• Report Number: 8030965-2016-14217
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971544
• 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,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• 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/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• 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