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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM CANNULATED CUTTER AWL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM CANNULATED CUTTER AWL Back to Search Results
Catalog Number 351.24
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Was no known reported patient involvement associated with the complained event. Udi: (b)(4). Implant and explant dates: device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter phone number: (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 that two cannulated cutter phenolic handles were found to contaminate the instrument set it was put into. There was no patient harm and no delay in procedure. There was no patient involvement reported. This report is for one (1) 11. 0mm cannulated cutter. This is report 1 of 2 for complaint (b)(4).

 
Manufacturer Narrative

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.

 
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Brand Name11.0MM CANNULATED CUTTER
Type of DeviceAWL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west cheater PA 19380
Manufacturer (Section G)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7061239
MDR Text Key93867291
Report Number2939274-2017-50037
Device Sequence Number1
Product Code HWJ
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number351.24
Device LOT NumberA4DC286
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/16/1994
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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