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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.111.720
Device Problem Device-Device Incompatibility (2919)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the locking screw was not blocked on the plate for radar palm distance on the top of the radial column of the plate. It was redirected using the variable angle guide but the result was always the same. For this reason, it was decided to withdraw it. This report is for one (1) 2. 4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/2h shaft/right. This is report 2 of 2 for (b)(4).

 
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Brand Name2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10800826
MDR Text Key215036150
Report Number2939274-2020-04988
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK083694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.111.720
Device LOT Number5L97437
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/06/2020 Patient Sequence Number: 1
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