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

Catalog Number 05.001.012VET

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.The device passed all testing and operational specifications.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a suplemental medwatch will be submitted accordingly.

Event Description

This is report 2 of 3 for the same event.It was reported that during an unspecified veterinary surgical procedure, it was observed that the electric pen drive device, hand switch device and cable device stopped functioning while being used together.According to the reporter, there was a five second and then a twenty second delay and then a thirty second delay with the device.The reporter stated there were no delays to the surgical procedure.It was unknown whether a spare device was available for use.It was reported that the surgery was successfully completed.There was no human patient involvement as this was a veterinary procedure.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: HAND SWITCH
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6682021
• MDR Text Key: 78983611
• Report Number: 8030965-2017-13386
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.012VET
• Device Lot Number: AV21785/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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