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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT 620MM REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT 620MM REAMER Back to Search Results
Model Number 352.044
Device Problem Material Twisted / Bent
Event Type  Malfunction  
Manufacturer Narrative

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, the flexible shaft tip was bent. It was unknown when the issue was discovered. There was no patient involvement. This complaint involves 1 device. This is report 1 of 1 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT 620MM
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9996529
Report Number2939274-2020-02036
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352.044
Device Catalogue Number352.044
Device LOT Number3L70662
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/22/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/24/2020 Patient Sequence Number: 1
Treatment
5.0MM FLEXIBLE SHAFT 620MM
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