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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 14MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 14MM SCREW, FIXATION, BONE Back to Search Results
Model Number 204.814
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

No patient involvement. Additional product codes: hrs, jds. Device was received damaged and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. A review of the device history records has been requested. 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 two deliveries were received containing empty device product packages on (b)(6) 2018. The first package from ups noted a missing locking compression plate (lcp) plate, the package was sealed on one end but unsealed on the other end. A device insert was enclosed in the package. Reportedly, indentations of a plate appeared on the package. The second package noted a missing two (2) cortex screws and a device inserts from each product. The box was sealed on both ends. Both ups shipper box was received intact. There is no patient involvement. This report is for one (1) 3. 5mm cortex screw. This is report 2 of 2 for (b)(4).

 
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Brand Name3.5MM CORTEX SCREW SELF-TAPPING 14MM
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7806771
MDR Text Key118094766
Report Number2939274-2018-53434
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number204.814
Device Catalogue Number204.814
Device LOT NumberH607297
Was Device Available For Evaluation? No
Date Returned to Manufacturer09/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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