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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VICE GRIP, LENGTH 180 MM PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC VICE GRIP, LENGTH 180 MM PLIERS,SURGICAL Back to Search Results
Model Number 391.88
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 synthes reports an event in (b)(6) as follows: it was reported a customer has a number of instruments that are not functioning correctly. Locking pliers has a jaw has limited range of motion and also cannot lock. A t-handle, quick coupling is not gripping onto tap properly. A countersink screwdriver is chipped with a warped screw head. No patient or surgical involvement. This is report 1 of 2 for (b)(4).

 
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Brand NameVICE GRIP, LENGTH 180 MM
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 Key9108825
MDR Text Key191533242
Report Number2939274-2019-60818
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number391.88
Device Catalogue Number391.88
Device LOT NumberT159103
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2018
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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