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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 4.9MM TI LOCKING BOLT 36MM PIN,FIXATION,SMOOTH

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SYNTHES USA 4.9MM TI LOCKING BOLT 36MM PIN,FIXATION,SMOOTH Back to Search Results
Catalog Number 459.360
Device Problem Failure to Align
Event Date 02/20/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). (b)(4) the patient undergoing revision surgery to remove misaligned device. 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. 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.

 
Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: on (b)(6) 2016, during proximal femoral nail (pfn) surgery, the surgeon experienced issues when drilling the distal locking bolt through the green sleeve assembly and the 125 degree aiming jig for pfna whereby the drill bit was reported to have been catching on the nail once through the near cortex. A 4. 9 mm locking bolt was inserted once the bone was drilled. The next day, the surgeon reviewed post-operative x-rays and found that the locking bolt had missed the aperture of the nail, thus the nail was not locked distally. The patient returned to the operating room on (b)(6) 2016 and the distal locking bolt was removed and a new bolt was inserted through the nail. This is report 1 of 5 for (b)(4).

 
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Brand Name4.9MM TI LOCKING BOLT 36MM
Type of DevicePIN,FIXATION,SMOOTH
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 Key5501916
Report Number2520274-2016-11664
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number459.360
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/15/2016 Patient Sequence Number: 1
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