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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 Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. A review of the device history records has been requested. 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

It was reported that during a routine inspection on (b)(6) 2018, the issue tabs on a rod introduction pliers for side-opening implants were found to be splayed. The sleeve is also stuck on the tube and will not move. It was also noted that the ratchet on another rod introduction pliers for side-opening implants falls off and will not stay on the instrument. There was no patient involvement. This report is for one (1) rod introduction pliers for side-opening implants. This is report 2 of 2 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 TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7950145
MDR Text Key123403684
Report Number2939274-2018-54281
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2018
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 Manufacturer09/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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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