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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Patient id/initials, age/date of birth, and weight are unknown the 510k: this report is for an unknown lag screw/unknown lot. Part and lot number are unknown; udi number is 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 surgery for a trochanteric fixation nail advance (tfna) for lag screw backing out. Patient was implanted on an unknown date with a tfna. X-rays were taken on an unknown date and showed that the lag screw was backing out. Patient was revised on (b)(6) 2017 to a non-synthes total hip. The tfna devices were removed fully intact. During removal the flexible screwdriver was discovered to be cracked. This discovery was made as the surgeon was entering the screwdriver into the nail and removing the lag screw. It is unknown if the crack was created prior to the procedure or during the procedure. The crack was reported to be on one of the screwdriver edges. No fragments were generated in the patient. The screwdriver was used to complete the procedure successfully with no issues. This report is for the revision procedure due to the lag screw backing out. The flexible screwdriver issue is being captured on related complaint (b)(4). Reported concomitant devices tfna nail (part/lot number unknown, quantity 1). This report is for an unknown lag screw. This is report 1 of 1 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wright lane east
west chester , PA 19380
6107195000
MDR Report Key7584167
Report Number2939274-2018-52446
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received06/26/2018
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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