MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DRILL BIT; UNKNOWN

Catalog Number UNK_PRODUCT

Device Problems Smoking (1585); Output below Specifications (3004)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/29/2016

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is event 2 of 2 of the same event.It was reported from (b)(6) that during surgery for a tibial diaphysis fracture, it was observed that smoke came out from the part of the radiolucent drive device where it was spinning the drill bit device.According to the report, the radiolucent drive device and the drill bit device started running idle when the surgeon tried to perform distal locking.The surgeon stated that it might have been due to low power on the radiolucent drive device which caused that drill bit device to not spin.There was a ten minute delay to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.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 subsequent follow-up, the reported stated that the procedure was performed on an elderly person.It was also mentioned that the drill device was not new and therefore did not work smoothly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT
• Type of Device: UNKNOWN
• 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: 5953084
• MDR Text Key: 55206082
• Report Number: 2520274-2016-14541
• Device Sequence Number: 1
• Product Code: HXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PRODUCT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• 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: RADIOLUCENT DRIVE DEVICE