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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS,SURGICAL Back to Search Results
Model Number 388.50
Device Problem Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device has been received, the investigation is in progress, 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 (b)(6) 2019 prior to start a posterior spinal fusion procedure, the scrub technician could not place a universal spinal system (uss) titanium (ti) collar onto the uss rod introduction pliers. After looking at the tube on the uss rod introduction pliers, it was discovered that the tube was bent (oblong). Another instrument was available for use prior to the surgery there was no patient involvement. Concomitant device reported: uss ti collar ( part# 498. 010, lot# unknown, quantity 1). This report is for one (1) rod introduction pliers for side-opening implants. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9227004
MDR Text Key194461111
Report Number2939274-2019-61722
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number388.50
Device Catalogue Number388.50
Device LOT NumberT134820
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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