MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS FOOT SWITCH-1 PEDAL FOR EPD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.016

Device Problem Difficult or Delayed Activation (2577)

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

Event Type  malfunction  

Event Description

This is report 3 of 3 of the same event.It was reported that during an unspecified surgical procedure, it was observed that the electric pen drive device would only go in reverse while in use with the foot pedal device and console.There was a delay to the surgical procedure.However, the duration of the delay was unspecified.A spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

Date returned to manufacturer: the date returned to manufacturer was documented as (b)(4) 2015 in the initial report.It has been updated as device not returned.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.

• Brand Name: FOOT SWITCH-1 PEDAL FOR EPD
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4843161
• MDR Text Key: 5941264
• Report Number: 3009450871-2015-12059
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.016
• Device Lot Number: 00890
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSOLE DEVICE