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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM SCREW, FIXATION, BONE Back to Search Results
Model Number 02.130.207
Device Problems Unsealed Device Packaging; Use of Device Problem; Appropriate Term/Code Not Available
Event Type  Malfunction  
Manufacturer Narrative

Additional pro-code: hrs. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: synthes rep. (b)(4). Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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, one of the screw packages did not have the variable angle (va) locking screw inside it during field inventory. The package was not altered or damaged in any way. There is no patient nor procedure involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

 
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Brand Name1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM
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 Key8984046
Report Number2939274-2019-60434
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 08/13/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.130.207
Device Catalogue Number02.130.207
Device LOT Number4L83630
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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