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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 Problems Break; Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Patient information is unknown. Date of event is unknown. The 510k: this report is for an unknown metaphyseal 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 manufacture date is unknown. 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 underwent an open reduction internal fixation (orif) of distal humerus with perpendicular plating using titanium va elbow system with medial plate and posterolateral plate on (b)(6) 2018. One month after surgery, x-ray was done and appeared to indicate possibility that one or more distal screws of posterolateral plate had backed out from plate along with a loss of reduction. On (b)(6) 2018, revision was performed and revealed that the locking screw and metaphyseal screw were backed out. Upon screw removal, the locking screw was found to be broken at junction of head element and shaft with an estimated broken length of 20 as checked by a surgical technician. Other screws removed from posterolateral plate were intact with no noted abnormalities. Posterolateral plate removed intact with no apparent abnormalities noted by customer. Medial plate and screws from the implantation surgery was left in place. There was an unknown surgical delay. There was an unknown patient outcome. No additional information provided. Concomitant device reported: unknown medial plate (part number unknown, lot number unknown, quantity 1) unknown posterolateral plate(part# unknown, lot# unknown, quantity 1) this is report 2 of 2 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 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7518447
Report Number2939274-2018-52199
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2018
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 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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