MAUDE Adverse Event Report: SYNTHES OBERDORF HAND SWITCH FOR ELECTRIC PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.012

Device Problems Sticking (1597); Difficult or Delayed Activation (2577)

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

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that prior to surgery during pre-testing, it was discovered that the hand switch for electric pen drive device had a sticky trigger.There were no delays to the planned surgical procedure as an identical spare 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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the finger extension was damaged.Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to usage wear over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HAND SWITCH FOR ELECTRIC PEN DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4793686
• MDR Text Key: 20150555
• Report Number: 8030965-2015-10750
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.012
• Device Lot Number: AV19044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1