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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION BIT,DRILL

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SYNTHES USA 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION BIT,DRILL Back to Search Results
Catalog Number 357.407
Device Problem Difficult To Position
Event Date 07/04/2016
Event Type  Malfunction  
Manufacturer Narrative

This device was used for treatment, not diagnosis. Udi#: (b)(4). Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. 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.

 
Event Description

It is reported that during an intertrochanteric right hip fracture procedure, the surgeon was drilling for placement of the final locking screw; the aiming arm caused the drill bit to go posterior to the nail. The surgeon believes there was a misalignment with either the handle or 130 degree guide or triple trocars, which may have caused the misalignment of the drill bit. There was a surgical delay of five (5) minutes, the surgeon completed the procedure successfully by taking the aiming arm off and freehanded the drilling and inserted the locking screw into the implanted devices. It was reported that post-operatively the patient's status is stable; there was no harm to the patient. Concomitant devices reported: 8. 0mm/4. 0mm drill sleeve 164mm, part #-357. 389, lot #-5690868, quantity (1); 11. 0mm/8. 0mm protection sleeve 153mm, part #-357. 386, lot #-5695340, quantity (1);trochanteric femoral nail (tfna), part#-456. 315s, lot number is unknown, quantity (1). This report is 4 of 4 for (b)(4).

 
Manufacturer Narrative

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

 
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Brand Name4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION
Type of DeviceBIT,DRILL
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5833227
Report Number2520274-2016-13707
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.407
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/29/2016 Patient Sequence Number: 1
Treatment
TROCHANTERIC FEMORAL NAIL (TFNA), PART#-456.315S
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