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

Catalog Number 05.001.082

Device Problems Device Slipped (1584); Malposition of Device (2616)

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

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

(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 before an orbital reconstruction surgery, it was discovered that as the scrub nurse was setting up the electric pen drive device for use, they noticed that the handswitch was not sitting properly in place and easily slipped off the handpiece device.According to the report, the patient was in the room but the device was not being used on the patient at the time.There was a five minute delay to the surgical procedure.A spare device was available to complete the surgery.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

The actual device was returned for evaluation.(b)(4) evaluated the device and determined that the hand switch for the air pen drive device was designed to work with the air pen drive device and not for the electric pen drive device.It was further determined that there was not a service manual or inspection for fitness for use available for this device.Therefore the device could not be tested.A visual inspection of the device was performed to complete the assessment.The reported condition was confirmed.The assignable root cause was determined to be due to improper use which is user error.If information is obtained that was not available, 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; 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: 5470553
• MDR Text Key: 39672935
• Report Number: 8030965-2016-11210
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093361
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• 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: AV21252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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