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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

Date of postoperative plate and screw back out is unknown. This report is for an unknown number of trauma screws/unknown lot. Part and lot number are unknown; udi number 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 patient underwent hardware removal and revision on (b)(6) 2018, due to a construct (plate and an unknown number of screws) that backed off of clavicle. The plate was originally implanted on (b)(6) 2018. The original surgery was successful and the surgeon was pleased with the outcome. Post-operatively, the once lateral fracture propagated more medially almost to a midshaft fracture. Noting this the surgeon thought that the patient may have fallen and mal-reduced and increased the length of the fracture. This could not be confirmed but the surgeon removed the originally implanted five-hole clavicle hook plate and revised the patient to a seven-hole clavicle hook plate. It is unknown if there was a surgical delay. The procedure was successfully completed. There was no patient consequence reported. Concomitant device reported: 3. 5mm lcp clavicle hook pl 5h 12mm hook depth/59mm/lt-ster (part # 241. 083s, lot # unknown, quantity 1). This report is for an unknown number of trauma 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 Key7621989
Report Number2939274-2018-52567
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2018
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 Received07/19/2018
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: 06/20/2018 Patient Sequence Number: 1
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