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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2019
Event Type  Malfunction  
Manufacturer Narrative

The device was 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, during a t10-ilium posterior spinal fusion with synthes spine uss, the tube of the rod introduction pliers for side-opening implant broke when putting in the rods. The fragment from the tube was retrieved and discarded. They were removed easily without additional intervention. Another persuader was already available so there was no surgical delay. The procedure was successfully completed. There was no harm to the patient. Concomitant device reported: unknown rods (part # unknown, lot # unknown, quantity # unknown). This complaint involves one (1) device. This report is for one (1) rod introduction pliers for side-opening implants. This is report 1 of 1 for (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 HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9188753
MDR Text Key180359554
Report Number2939274-2019-61529
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,Followup
Report Date 09/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2019
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 Number5660588
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/17/2007
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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