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

Catalog Number	05.001.012
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Concomitant devices: attachment devices, hand switch device, handpiece device.Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 4 of 5 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the electric pen drive device had a bad contact and would sometimes stop when used with three attachment devices, a hand switch device, and a handpiece device.It was reported that there was no delay in the procedure due to the event as an unspecified spare device was available for use.It was reported that the procedure was successfully completed.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 FOR ELECTRIC PEN DRIVE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7104209
• Report Number: 8030965-2017-50467
• Device Sequence Number: 1461240
• Product Code: HWE
• UDI-Device Identifier: 07611819167735
• UDI-Public: (01)07611819167735(11)150710(10)AV00006/2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.012
• Device Lot Number: AV00006/2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1