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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 456.317S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 08/17/2018
Event Type  Injury  
Manufacturer Narrative
Additional product code hwc. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 on (b)(6) 2018, during a trochanteric fixation nail-advanced (tfna) procedure, an 11mm/125 degree titanium cannulated trochanteric fixation nail (170mm) was inadvertently selected for implantation. The surgeon had difficulty when attempting to implant the nail. The correct, larger, nail (11 mm/130 degree titanium cannulated tfn-a) was then selected and switched onto the aiming arm for successful implantation. There was a 20-minute surgical delay reported. The procedure was successfully completed. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7874324
MDR Text Key120238574
Report Number2939274-2018-53761
Device Sequence Number1
Product Code HSB
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number456.317S
Device Catalogue Number456.317S
Device Lot Number7370479
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 Received10/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
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: 09/13/2018 Patient Sequence Number: 1
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