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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE,DEPTH Back to Search Results
Catalog Number 319.04
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. The device was 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 an unknown date during routine incoming inspection, the deep gauge was observed to have a missing piece. There was no patient involvement. This complaint involves one (1) device. This is 1 of 1 fro report (b)(4).
 
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Brand NameDEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
Type of DeviceGAUGE,DEPTH
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 Key9371232
MDR Text Key194666015
Report Number2939274-2019-62377
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
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 11/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.04
Device Lot NumberH391106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/05/2018
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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