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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 Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

510k: this report is for three (3) unknown 3. 5 cortex screws /unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer. 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 the patient¿s ankle surgery was revised because she was non-compliant and walked on it too early causing the screws to loose purchase in the bone. This led to instability of the ankle and reoperation. Three unknown 3. 5 cortex screws were removed intact and were not broken and 4 cortex screws were added for syndesmosis fixation. Revision procedure was successful and patient outcome is reported as stable. Original surgery was (b)(6) 2018. This report is for three (3) unknown 3. 5 cortex screws. This is report 1 of 1 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 Key7596567
Report Number2939274-2018-52487
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
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 Received05/16/2018
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: 06/13/2018 Patient Sequence Number: 1
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