MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.010

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Sticking (1597); Vibration (1674); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation for freezing up and making grinding noises.Reliability engineering evaluated the device and observed that the device failed the power test with test bench (result: 38.72w, specification: min.40w ¿ max.65w), the trigger was sticking, the device was running roughly, noisy and vibrating.It was also observed that the device was corroded and had an unknown residue on the internal components.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during testing, it was observed that the small battery drive device was making grinding noises and freezing up.During in-house engineering evaluation, it was observed that the device failed the power test with test bench (result: 38.72w, specification: min.40w - max.65w), was running roughly, noisy and vibrating and had sticky triggers.It was not reported if there were any delays to the planned surgical procedure.A spare identical 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: SMALL BATTERY DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: 5584880
• MDR Text Key: 43782508
• Report Number: 8030965-2016-13235
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.010
• Device Lot Number: 003889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2009
• 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