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

Catalog Number 530.610

Device Problem Device Stops Intermittently (1599)

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

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's phone number was not provided.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 2 of 2 for the same event.It was reported that during a total knee replacement surgical procedure it was observed that two battery oscillator devices had intermittent operation in the same procedure.The event occurred 4-5 minutes into the cutting of the knee.It was reported that there was no delay to the procedure as unspecified spare devices were available and the procedure was successfully completed.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed or duplicated.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device made an unusual noise, the saw head got hot, bearings were damaged (rough rotation), the electric motor and the saw head were worn (cosmetically unacceptable).The assignable root cause was determined to be due normal wear from use over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: BATTERY OSCILLATOR
• 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: 5311760
• MDR Text Key: 34682636
• Report Number: 8030965-2015-12456
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.610
• Device Lot Number: 4299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2010
• 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