MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SMALL AIR DRILL SINGLE HOSE; INSTRUMENT, BENDING OR CONTOURING

Catalog Number 511.10

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that the air drill device had a sticky trigger.It was not reported if the device was used in surgery.It was not reported if there were any delays or if a spare device was available for use.It was reported that this was a veterinary equipment; therefore, there was no human patient involvement.It was not reported if there were any 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.

• Brand Name: SMALL AIR DRILL SINGLE HOSE
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; ni
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5888568
• MDR Text Key: 53450381
• Report Number: 8030965-2016-14594
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2015
• 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