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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 height reported as 185. 42 cm date of event: unknown. This report is for eight (8) unknown 3. 5mm cortex screws/unknown lot. Part and lot numbers 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 on (b)(6) 2018 the patient was implanted with a 3. 5mm reconstruction plate, one (1) 2. 0mm locking compression plate, eight (8) 3. 5mm cortex screws and two (2) 2. 0mm cortex screws. On march 12, 2018 the patient had a revision due to patient re-injured the clavicle by returning to work against advisement of doctor. On the same date the patient had a hardware removal due to a broken screw and the screws were backing out. Fragments generated from broken screw was removed easily. Procedure was completed without any complications and without any surgical delay. None of the pre, post or intra-operative x-rays from initial or revision surgery are available. Concomitant devices reported: 3. 5mm lcp reconstruction plate (part 245. 101, lot number unknown, quantity 1), 2. 0mm lcp plate (part 247. 347, lot number unknown, quantity 1). This report is for eight (8) unknown 3. 5mm cortex screws. This is report 1 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 Key7398091
Report Number2939274-2018-51461
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2018
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 Received03/11/2018
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

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