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 Type  malfunction  

Event Description

It was reported from germany that during an unspecified surgical procedure on the knee joint, it was observed that the power drive device stopped performing.It was reported that after several attempts to resume function, the device started functioning and then stopped again.It was reported that there was no significant delay in the procedure as an unspecified spare device was available for use.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact event date is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the motor seized and was running rough.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear of component parts over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 4041145
• MDR Text Key: 4902144
• Report Number: 8030965-2014-10464
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 530.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1