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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

This report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Implant date 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 on (b)(6) 2018, the patient had a bone graft harvested to fill a bone void in the right humerus. This also included revision surgery due to chronic non-union, radial nerve palsy and infection. The masquolet technique was performed for the bone void. Locking screws were still locked into the locking compression (lcp) extra articular distal humerus plate, but the distal portion of the humerus bone pulled away from the plate. The surgeon reduced the fragment back to the plate and implanted new screws. The plate remained in the patient. Only four (4) screws were replaced in the distal portion of the plate after the surgeon reduced the bone. Patient and surgical outcome are unknown. This is report 1 of 3 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 Key7894989
Report Number2939274-2018-53891
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
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 Received09/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/20/2018 Patient Sequence Number: 1
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