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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problems Fall (1848); Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Customer quality (cq) engineer reviewed the 2 provided x-rays and could not definitively confirm the complaint condition. There is not sufficient evidence based on the angles of the 2 provided x-rays to confirm the complaint condition from an engineering perspective. The angles of the provided x-rays were not sufficient to determine the location/position of the implants with respect to each other. Corrected data: patient weight reported as (b)(6). 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.
 
Manufacturer Narrative
This report is for one (1) unknown helical blade. Without the specific part and lot number, the udi is not available. Complainant device is not expected to be returned for manufacturer review/investigation. The (510k): unknown, as specific part and lot numbers for helical blade is not provided. (b)(4) used to capture additional medical/surgical intervention required. 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
It was reported that patient underwent a trochanteric fixation nail advanced (tfna) removal and conversion to a total hip prosthesis on (b)(6) 2017. The date of the original tfna procedure was (b)(6) 2017. Subsequently, the patient sustained a fall, and it was discovered that there was helical blade cut-out in the anterior portion of the femoral head. Removed hardware included the tfna construct: cephalomedullary nail, helical blade, and locking screw ¿all intact. A total hip prosthesis was then implanted. Nothing untoward occurred during this procedure. The procedure was completed successfully with the patient in stable condition. The surgeon stated that in his opinion, the original helical blade may have been placed too inferiorly and anteriorly, possibly contributing to the cut-out. Concomitant devices reported: 11 mm/130 degree ti cannulated tfna 235 mm/left - sterile (part #-04. 037. 145s; quantity 1), 5 mm locking screw (quantity 1). This report is for one (1) unknown helical blade. This is report 1 of 1 for complaint (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6846383
MDR Text Key113593177
Report Number2520274-2017-12218
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received10/13/2017
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: 09/06/2017 Patient Sequence Number: 1
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