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

Catalog Number 530.610

Device Problems Vibration (1674); Battery Problem (2885)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the device not oscillating was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device emitted an unusual noise.It was further determined that the electric motor was damaged.It was observed that the device had a rough rotation (vibration) and corrosion.It was further determined that the o-rings were damaged and the bearings were worn.The assignable root cause was determined to be due to component wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during pre-surgery, it was discovered that the battery oscillator device would not oscillate.During in-house engineering evaluation, it was observed that the device had a rough rotation (vibration).There were no delays to the surgical procedure as a spare device was available for use.There was no patient involvement reported.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.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5888734
• MDR Text Key: 53465367
• Report Number: 8030965-2016-14597
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• 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: 4143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2010
• 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