MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS EPD 60000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.010

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) the lot number was unknown.Therefore, device manufacture date is unknown.The manufacturing location was unknown.Reporter's phone number was not provided.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 Description

It was reported from (b)(6) that during a vascular bone graft surgical procedure on a finger, it was observed that the on/off switch on the electric pen drive device would not move easily to the "off" position while in use with the hand switch device to remove the k-wire device.As a result, the hand switch device was activated by accident, resulting in the blood supply being cut off and making the procedure a non-vascular bone graft instead.Therefore, the patient treatment was different to what was planned.It was further clarified that the event occurred while the surgeon was obtaining a bone graft from another part of the same hand that was vascularized while flipping it carefully to place into the finger as the vascular connection was very delicate and tenuous.It was reported that once this connection was broken due to the hand switch causing the trigger to operate out of the surgeon's control when removing the k- wire, the vascular connection was broken making the bone graft a non-vascular treatment.There was no delay to the surgical procedure.It was reported that the surgeon was able to switch the electric pen drive device to the lock position after the event and remove the k-wire successfully with the same electric pen drive device.There was patient involvement reported.It was reported that the patient's response was fine; however, the surgeon would have preferred a vascular bone graft surgery which would have been the ideal treatment for the patient.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: EPD 60000 RPM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5935777
• MDR Text Key: 54179581
• Report Number: 8030965-2016-14743
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: HAND SWITCH DEVICE; K-WIRE DEVICE
• Patient Outcome(s): Required Intervention