MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS HAND SWITCH FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number 05.001.082

Device Problem Device Slipped (1584)

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

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 Description

It was reported from (b)(6) that during a midface reconstruction surgical procedure, it was observed that while the scrub nurse was setting up the electric pen drive device for use, they noticed the hand switch device was not sitting properly in place and it easily slipped off the handpiece device.It was reported that the event occurred before use on a patient.There was a five minute delay to the surgical procedure.A spare device was available to complete the procedure.It was reported that a piece of the attachment did not break or fall inside the patient.According to the reporter, it was unclear why the device user was assembling an air pen hand switch device to an electric pen drive device.It was reported that there was no allegation of malfunction against the electric pen drive device.There was 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

During a subsequent follow-up, the reporter clarified that there was no alleged malfunction against the device.Therefore, it was determined that this event could not have caused or contributed to a serious injury and/ or death.Reporting for this event is therefore completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HAND SWITCH FOR AIR PEN DRIVE
• Type of Device: MOTOR, DRILL, PNEUMATIC
• 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: 5846992
• MDR Text Key: 52413252
• Report Number: 8030965-2016-14431
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.082
• Device Lot Number: 3848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• 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