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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES PLIERS,SURGICAL Back to Search Results
Model Number 391.965
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Reporter is synthes sales consultant. 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, the combination bending/cutting pliers prong that pushes against both grip handles is snapped off. This was not used during the case but just recognized during pre-op. There was no patient involvement. This report is for one (1) combination bending/cutting pliers f/1. 0 mm - 2. 0 mm plates. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameCOMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES
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 Key8800037
MDR Text Key151353757
Report Number2939274-2019-59245
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number391.965
Device Catalogue Number391.965
Device LOT Number4562685
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated By Manufacturer? Yes
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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