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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 Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Pma# ¿ 510k: this report is for an unknown 90 mm length helical blade/unknown lot. Part and lot number are unknown; udi number is unknown. Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. 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 the patient had an original surgery performed for an inter-trochanteric femoral fracture on (b)(6) 2016. The patient presented with pain on an unknown date and revision surgery was performed on (b)(6) 2016. The construct that was explanted was one (1) 10 mm/130 mm degree, 170 mm length trochanteric femoral fixation nail, one (1) 90 mm length helical blade and one (1) 5. 0 mm locking screw 30 mm. It was reported that the nail construct was removed with no issues and in good condition. The patient was revised to a depuy total hip replacement. The surgery was completed successfully, and the patient is reported in stable condition. This report is for an unknown 90 mm length helical blade. This is report 3 of 3 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 Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6215551
MDR Text Key63634435
Report Number2520274-2016-15811
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 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received12/05/2016
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: 12/30/2016 Patient Sequence Number: 1
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