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

Catalog Number 532.110

Device Problems Device Stops Intermittently (1599); Mechanical Jam (2983)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the bottom trigger was sticking and the motor would run by itself was confirmed.An assessment was performed and it was observed that the bottom trigger was binding and sticking when it was pressed, the device showed signs of an immersion, there was excessive corrosion in the internal sub-assemblies¿ components, unknown debris on the ball bearings, the triggers were corroded, and the motor was corroded.It was further determined that the device failed pretest for check off/oscillation/on switch mode function, check continuously oscillating, and the trigger and electronic control unit (ecu) function check.The assignable root cause was determined to be due to improper cleaning, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the bottom trigger on the small battery drive device was sticking and making the motor run without being pressed.It was reported that the trigger was put out to get the motor to stop running.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was 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 will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7393425
• MDR Text Key: 104560955
• Report Number: 8030965-2018-52726
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819408357
• UDI-Public: (01)7611819408357(11)150315
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 03/09/2018
• Date Device Manufactured: 03/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1