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

Catalog Number 532.110_LL

Device Problems Sticking (1597); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 service and repair/pre-testing, it was observed that the reverse trigger on the small battery drive device was sticking, the device would not run and one of the discs was missing.The event was not related to surgery.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.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device would not run, the triggers were sticky, and one of the safety discs was missing, the electronic control unite was damaged, the triggers were worn and the internal components were corroded.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to worn components from normal 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.

• Brand Name: SMALL BATTERY DRIVE II
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5994813
• MDR Text Key: 56585539
• Report Number: 8030965-2016-15046
• Device Sequence Number: 1
• Product Code: HWE
• 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: company representative,health
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110_LL
• Device Lot Number: 1368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• 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