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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¿s weight is unknown. Date of event: date of postoperative locking screws protrusion through the head of the humerus into the joint is unknown. This report is for unknown number of unknown locking screws. Part and lot numbers are unknown. Without the specific part and lot number, the udi number is not available. Date of original implant is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (510k): unknown, as specific part and lot numbers for screw is not provided. 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 a humerus plate and an unknown number of locking and cortical screws were explanted on (b)(6) 2018. The devices, implanted on an unknown date, were removed because some of the locking screws had protruded through the head of the humerus into the joint. The surgeon took off the plate and the screws as the fracture had healed. There were no surgical delays, no additional medical intervention was required and the devices were explanted intact. The surgery was successfully completed with a good surgical outcome and the explanted devices were discarded. All available information has been reported. The reporter was not in the room during the explant and did not know the original implant date. Concomitant devices reported: humerus plate (part # unknown, lot # unknown, quantity 1), cortex screws (part # unknown, lot # unknown, quantity unknown). This report is for unknown number of unknown locking screws. This is report 1 of 1 for complaint (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 Key7484666
Report Number2939274-2018-51998
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2018
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 Received04/11/2018
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

Patient TREATMENT DATA
Date Received: 05/03/2018 Patient Sequence Number: 1
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