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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 55MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 55MM SCREW, FIXATION, BONE Back to Search Results
Model Number 204.855
Device Problem Manufacturing, Packaging or Shipping Problem
Event Type  Malfunction  
Manufacturer Narrative

Additional product codes: hrs, jds. Initial reporter is a synthes employee 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, it was observed that cortex screw self-tapping had two (2) parts in the bag when there should have been one (1) part. There was no patient involvement. This report is for a cortex screw. This is report 1 of 1 for (b)(4).

 
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Brand Name3.5MM CORTEX SCREW SELF-TAPPING 55MM
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8875120
Report Number2939274-2019-59589
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 Number204.855
Device Catalogue Number204.855
Device LOT NumberH848886
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 Received08/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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