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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES USA 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.003.026S
Device Problem Failure to Align (2522)
Patient Problems Sedation (2368); Blood Loss (2597); No Code Available (3191)
Event Date 03/09/2016
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting. (b)(4) although the exact desired result was not obtained, the device was not removed. Remains in situ. The complainant parts are not expected to be returned for manufacturing review/investigation. (b)(6). (b)(4). Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device 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: it was reported that a patient underwent a proximal femur nailing procedure on (b)(6) 2016. The utilized screws were designed to be inserted along a specified path with the assistance of a zig/aiming arm. However, the screw did not go through properly and wound up missing the nail. The surgeon opened the fracture site and manually corrected the screw position with the use of bone cement. In doing so, a suboptimal result was achieved. The procedure was completed with a two (2) hour delay and additional blood loss due to the required medical intervention. This report is 1 of 4 for (b)(4).
 
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Brand Name6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5519399
MDR Text Key40939421
Report Number2520274-2016-11794
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
PK040336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.003.026S
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 Received03/09/2016
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: 03/23/2016 Patient Sequence Number: 1
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