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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC HELICAL BLADE F/TFN Ø11 L90 TAN GOLD ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE: SYNTHES USA PRODUCTS LLC HELICAL BLADE F/TFN Ø11 L90 TAN GOLD ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 456.303
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
It is unknown when the event occurred. (b)(4). This report is for helical blade/unknown lot. Lot number are unknown. 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 patient had a revision on (b)(6) 2017, due to helical blade was sticking out. Patient was implanted with trochanteric fixation nail, date unknown. Patient began to have pain of the hip at the joint, x-ray was taken, date unknown, it was noticed that the helical blade was sticking out significantly lateral because the bone had collapsed. It was reported that the device functioned correctly by sliding and not cutting out the femoral head, but caused the patient pain on the lateral side of the hip. Helical blade was removed and a shorter was implanted. Concomitant device(s) reported: tfn nail (part # unknown, lot # unknown, quantity 1). This complaint involves one (1) device. This report is for 1 (one) helical blade. (b)(4).
 
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Brand NameHELICAL BLADE F/TFN Ø11 L90 TAN GOLD
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19083
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19083
6107195000
MDR Report Key7154480
MDR Text Key96042531
Report Number2939274-2017-50483
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982226679
UDI-Public(01)10886982226679(10)UNKNOWNLOT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
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 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number456.303
Device Catalogue Number456.303
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 Received12/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/29/2017 Patient Sequence Number: 1
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