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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown tibial nail/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device has not been explanted. 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 during a procedure on (b)(6) 2018, the cannulated connecting screw for suprapatellar tibial nail set was extremely difficult to remove following the implantation of the nail. A standard t-handle ball hex screwdriver and a 11mm ratchet wrench had to be used in conjunction to loosen and remove the connecting screw. The surgery was completed successfully with no reported patient consequence. Concomitant parts: t-handle ball hex screwdriver 8mm (part: 03. 010. 517, lot: unknown, quantity: 1), ratchet wrench 11mm width across flats (part: 321. 20, lot: unknown, quantity: 1). This report is for an unknown tibial nail. This is report 2 of 2 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7586990
MDR Text Key110623178
Report Number2939274-2018-52449
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 05/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received05/17/2018
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

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