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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Sedation (2368); No Code Available (3191)
Event Date 03/21/2016
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting. This report is for one (1) unknown tfna nail. Without a valid part and lot number, the udi is not available. The original implant procedure was performed on an unknown date. Per the facility, the complainant parts were discarded and are no longer available for evaluation. (b)(6). (b)(4). As specific part and lot numbers for the complainant tfna nail were not provided. 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 revision procedure to have previously implanted trochanteric fixation nail advanced (tfna) hardware removed. During removal of the implants, one of the 5. 0mm locking screws (bolt) snapped into two (2) pieces. As a result, the far end of the screw fragment remained lodged in the far cortex of the bone, partially engaging the screw hole of the nail. All of the other screws were successfully removed without incident. Then, the surgeon decided to attempt extraction of the nail with the screw fragment still in situ. During this attempt to remove the tfna nail from the medullary canal, however, the screw fragment retained purchase in the patient's bone, causing a fracture in the distal femur. Initially, the plan was to remove the tfna hardware and revise the patient to a total hip replacement. However, this plan was abandoned as a result of the distal femur fracture. The patient was instead plated with a less invasive stabilization system (liss) locking compression distal femur (lcp-df) plating system. The new hardware had to be borrowed from a geographically separate hospital site, which created a ninety (90) minute surgical delay. Additional information pertaining to patient outcome is unknown. The reason for the hardware removal is unknown. This report is for one (1) unknown tfna nail. This report is 2 of 2 for (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 (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5564402
MDR Text Key42262937
Report Number2520274-2016-12021
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberUNKNOWN
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 Received03/21/2016
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: 04/08/2016 Patient Sequence Number: 1
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