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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 REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Model Number 352.040
Device Problem Device-Device Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

Reporter: 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 (b)(6) 2019, a reamer shaft is not accepting reamer heads during inspection at sterile processing department. There was no patient involvement. Concomitant device reported: unknown reamer heads (part # unknown, lot # unknown, quantity # unknown). This is report 1 of 1 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
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 Key8934890
Report Number2939274-2019-60119
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352.040
Device Catalogue Number352.040
Device LOT NumberL946443
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/27/2019 Patient Sequence Number: 1
Treatment
UNK - REAMERS: REAMER HEAD
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