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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 Collapse (1099)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Patient date of birth/age and weight are unknown. Date of post-operative event is unknown. This report is for one (1) unknown tfn nail. Without a valid part and lot number, the udi is not available. The complainant part has not been explanted. As the device remains in the patient, an evaluation cannot be performed. (b)(4) used to report that the potential exists for instability of the construct due to the locking mechanism¿s malfunction. As specific part and lot numbers for the complainant tfn 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
It was reported that a patient was originally treated for a femoral neck fracture on (b)(6) 2015 with the implantation of a short trochanteric fixation nail (tfn). Upon review of follow-up x-rays taken on (b)(6) 2016, the surgeon noticed that the locking mechanism on the tfn had collapsed and rotated. As the patient had fully healed, a revision surgery will not be required. At this time, the patient status is said to be "stable". This report is for one (1) unknown tfn 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 Key5480102
MDR Text Key39663828
Report Number2520274-2016-11461
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
Report Date 02/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUNKNOWN
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 Received02/17/2016
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: 03/04/2016 Patient Sequence Number: 1
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