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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) 4.9MM TI LOCKING BOLT 42MM PIN, FIXATION, SMOOTH

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SYNTHES (USA) 4.9MM TI LOCKING BOLT 42MM PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number 459.420
Device Problem Failure to Align
Event Type  Injury  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Patient weight is unknown. (b)(4). Complainant part is not going to be returned concomitant medical devices: blade (unknown part #, unknown lot #, quantity of 1); aiming arm (unknown part #, unknown lot #, quantity of 1); insertion handle: (unknown part #, unknown lot #, quantity of 1). (b)(6). Device is not distributed in the united states, but is similar to a device marketed in the usa. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. Based on the complaint description, without material, no further investigation is possible. Per dhr review of the known lot numbers were the parts manufactured according to the specification. We can only declare that for the products 472. 265s and 459. 420 we use only raw material which corresponds the astm f1295 specification and the international standards iso 5832-11. The article 472. 265s with lot no 9099385 was manufactured in a quantity of (b)(4) pieces on august 2014. We are not aware of any quality problems or failures caused by a faulty product on the article. Also we are not aware of any other complaint for this article- and lot number combination. 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 europe reports an event in australia as follows: it was reported by the surgeon that a 4. 9 locking bolt missed the aperture in the nail. This was discovered on (b)(6) 2016 during post-op lateral view x-rays that were taken 3 days after proximal femoral nail antirotation (pfna) surgery. In the surgeon¿s opinion, he states that this probably occurred due to the small diameter of nail which was too small for the patient¿s anatomy. In addition, excessive force may have been placed on insertion handle/aiming arm during drilling of distal locking bolt causing drill and locking bolt to skive and miss the nail. Original implant date occurred on (b)(6) 2016. Surgeon revised the nail successfully on (b)(6) 2016. Concomitant medical devices reported: blade (unknown part #, unknown lot #, quantity of 1); aiming arm (unknown part #, unknown lot #, quantity of 1); insertion handle: (unknown part #, unknown lot #, quantity of 1). This is report 2 of 2 for (b)(4).

 
Manufacturer Narrative

Date of event: unknown. (b)(4). 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 Name4.9MM TI LOCKING BOLT 42MM
Type of DevicePIN, FIXATION, SMOOTH
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 Key5726676
Report Number2520274-2016-13174
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number459.420
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 Received06/20/2016
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? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/15/2016 Patient Sequence Number: 1
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