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 Sticking (1597); Device Stops Intermittently (1599); Noise, Audible (3273)

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

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed which found the device ran intermittently and made an unusual grinding noise and the upper trigger was sticking.The assignable root cause was determined to be due to component wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during pre-surgery testing it was observed that the small battery drive device had intermittent operation.During in-house engineering evaluation, it was found that the device ran intermittently and made an unusual grinding noise and the upper trigger was sticking.It was reported that there was no delay in the scheduled surgical procedure and a spare device was available for use.It was reported there was no 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.

• 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: 5467761
• MDR Text Key: 39584690
• Report Number: 8030965-2016-11199
• Device Sequence Number: 1
• Product Code: HWE
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• 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: 003942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2010
• 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