MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS POWER DRIVE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.100

Device Problems Loss of Power (1475); Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (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 the power drive device had no power and did not perform.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays to a surgical procedure.A spare device was not available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the motor was seized and rough running.It was further determined that the motor was blocked as well.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: POWER DRIVE
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5180010
• MDR Text Key: 30060269
• Report Number: 3009450871-2015-13900
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2008
• 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