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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 DUAL-OPENING IMPL F/6.0MM RODS PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS PLIERS,SURGICAL Back to Search Results
Model Number 388.509
Device Problems Device-Device Incompatibility (2919); Device Difficult to Maintain (3134)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter: synthes sales representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. 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.

 
Event Description

It was reported that on (b)(6) 2019, during a pre-operative procedure, the rod introduction pliers for dual-opening implant were unable to hold collars when trying to load them onto the instrument before starting a case. Two techs tried multiple times with multiple collars and were not successful in loading the collars to either of the persuaders. There were no reports of injury, medical intervention and no prolonged hospitalization. There was no patient involvement. This complaint involves three (3) devices. This report is for one (1) rod introduction pliers for dual-opening impl f/6. 0mm rods. This report is 1 of 3 for (b)(4).

 
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Brand NameROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS
Type of DevicePLIERS,SURGICAL
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8345176
MDR Text Key137523246
Report Number2939274-2019-56496
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number388.509
Device Catalogue Number388.509
Device LOT NumberH387389
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2018
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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