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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 9MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 9MM SCREW, FIXATION, BONE Back to Search Results
Model Number 02.214.109
Device Problem Manufacturing, Packaging or Shipping Problem
Event Type  Malfunction  
Manufacturer Narrative

Additional product code: hrs. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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, during incoming receipt of a replenishment order, the bag for the cortex screw self taping with t4 star drive recess was observed to be empty when there should have been one part in the bag. There was no known hospital or patient involvement. This report is for a cortex screw. This is report 1 of 1 for (b)(4).

 
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Brand Name1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 9MM
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 Key8875266
Report Number2939274-2019-59591
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.214.109
Device Catalogue Number02.214.109
Device LOT Number2L95589
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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