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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM SCREW, FIXATION, BONE Back to Search Results
Model Number 04.130.211
Device Problem Manufacturing, Packaging or Shipping Problem
Event Type  Malfunction  
Manufacturer Narrative

Additional device product code: hrs. 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 an unknown date, the double drill sleeve for 1. 5 mm cortex screw/red was broken. Upon receiving new titanium variable angle modular hand set and a titanium variable angle locking screw, self tapping with star drive recess 11 mm was received with empty screw package. There was no patient involvement. This is report 2 of 2 for (b)(4).

 
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Brand Name1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ  2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8951786
Report Number2939274-2019-60226
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number04.130.211
Device Catalogue Number04.130.211
Device LOT Number4L72045
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/24/2019
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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