MAUDE Adverse Event Report: SYNTHES USA; DRILL BIT

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 10/20/2014

Event Type  Injury  

Event Description

It was reported that a male patient underwent an open reduction internal fixation hip fracture surgery on (b)(6) 2014.The trochanteric fixation nail (tfn) system was used with a short nail.As the surgeon was assembling the system, the metal trocar got stuck in the black aiming arm.The surgeon used a mallet to get the trocar into the aiming arm, then attempted to drill the distal screw but missed the nail completely.The screw was removed and it was decided that the screw was not needed.The surgery was successfully completed with a surgical delay of an hour.No patient harm was reported.This report is of 6 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown drill bit/unknown lot number.Device is an instrument and is not implanted/explanted without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4245207
• MDR Text Key: 5106642
• Report Number: 2520274-2014-14658
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/12/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 90