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

Catalog Number 530.100

Device Problem Loss of Power (1475)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the power drive device stopped working.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of the event was unknown; however, the reporter stated that the event was discovered on (b)(6) 2014.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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device did not run when power was applied.Therefore, the reported condition was confirmed.The assignable root cause was determined to be most likely due to motor assembly or electronic failure due to normal wear and usage over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POWER DRIVE
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3955358
• MDR Text Key: 17157405
• Report Number: 8030965-2014-10417
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.100
• Device Lot Number: 34156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1