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 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

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 supplemental medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event.It was reported that during an unspecified surgery, it was observed that the battery oscillator device was operating intermittently.An identical spare device was used; however, yielded the same results.A third identical spare device was used to complete the surgery.There were no delays reported to the surgical procedure.There was patient involvement.There were no reports of injuries, 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 observed that the device has intermittent operation and vibration.It was determined that the electronic control unit was damaged, the electric motor had extreme vibration, the o-rings were damaged, and the bearings and saw-head were worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 5204770
• MDR Text Key: 30806021
• Report Number: 3009450871-2015-14112
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• 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: 4283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1