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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT REAMER

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SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Fitting Problem
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. No patient involvement reported. Date of event: unknown. Device is an instrument and is not implanted/explanted. Date returned to manufacturer. Device history records review was conducted. The report indicates that the: part # 352. 040 and lot # 9650042. Manufacturing location: (b)(4). Manufacturing date: 03. Nov. 2015. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. 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 the top of the reamer shaft is not connecting with reamer heads. This was discovered in sterile processing. There was no patient involvement. This complaint involves one device. Concomitant devices reported:reamer head (part # unknown, lot # unknown, quantity # 1). This report is 1 of 1 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ  CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ  CH2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7026503
Report Number9612488-2017-10577
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number9650042
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/03/2015
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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