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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 Problems Break; Material Fragmentation
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional narrative: patient information was not provided by reporter. Event date: unknown. Although requested, additional information was not provided for reporting. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. A product development investigation was performed for the subject device. The flexible shaft distal tip as found to have twisted prongs, one of which was broken (missing approximately 5mm ¿ measured with calipers ca94). The complaint condition was confirmed. The flexible shaft (352. 040) and 8. 5mm reamer head (352. 085) are utilized in operations when reaming is utilized and is noted in eight (8) technique guides including: titanium cannulated tibial nail, adolescent lateral entry femoral nail (alif) and reamer/irrigator/aspirator (ria). In use, a cutting head (starting with 8. 5mm and moving up in 0. 5mm increments) is attached to the distal end of the flexible shaft and inserted under power over a reaming rod per the titanium cannulated tibial nail technique guide. The relevant drawing for the returned instrument was reviewed. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. No definitive root cause was able to be determined as method of use at time of failure is unknown. The received condition is consistent with the reamer head becoming stuck during use resulting in a twisted/broken flexible shaft tip and a broken reamer head. 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 an 8. 5mm medullary reamer head and a 5. 0 flexible reamer shaft broke during a tibial nail procedure on an unknown date. This report is 2 of 2 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
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5449014
Report Number9612488-2016-10101
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number8708956
OTHER Device ID Number(01)10886982194114(10)8708956
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2014
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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