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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER

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SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER Back to Search Results
Catalog Number 351.16J
Device Problems Failure To Adhere Or Bond; Device Operates Differently Than Expected
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Device is expected to be returned for manufacturer review/investigation, but has yet to be received. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. S&r service history review has been requested. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

The service and repair department reported that the flexible shaft connector for use with jacobs chuck, adapter would not hold the reaming shaft. It kept disconnecting while the surgeon was reaming back out. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the adapter would not hold the reaming shaft. The repair technician reported the chuck pin was missing. Missing parts is the reason for repair. The item is not repairable. The cause of the issue is unknown. This item was forwarded to the complaint handling unit. The evaluation was confirmed. A product investigation was completed: the instrument was received assembled and upon visual inspection of the device it appeared that one of the guide pins was missing from the connector, the complaint device was then disassembled and it was confirmed that the one of the guide pins was missing from the device preventing it from functioning as intended. The returned condition is consistent with having been disassembled. Even thou the set screw is loctite in place to prevent disassembly, it is a common practice for a device to be disassembled by force, if possible, for cleaning/reprocessing. Thus, while it cannot be definitively determined, it is most probable that disassembly for cleaning, and subsequent loss of the pins and/or improper reassembly of the device led to the complaint condition. Per the technique guide, the flexible shaft handle is part of the flexible reamer sets and used if reaming of the medullary canal is desired for implantation of retrograde/antegrade femoral nails (r/afn), lateral femoral nails (lfn), and cannulated tibial nails. A review of the current design drawing and the manufactured revision was performed. The design history was found to not impact the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. This failure mode is typically associated with lost parts as a result of disassembly during sterilization. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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 there was a five (5) minute delay in the procedure.

 
Manufacturer Narrative

Service history review: part no: 351. 16j, lot no: 8053605 can be performed because the lot number is unknown and cannot be traced. The manufacture date is unknown. The service history evaluation is unconfirmed. Service history review: part no: 351. 16j, no service history review can be performed as this is a lot controlled item. The manufacture date of this item is 12-sep-2012. The source of the manufacture date is the release to warehouse date. The service history evaluation is unconfirmed. 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.

 
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Brand NameFLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach PA 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 Key5135995
Report Number2520274-2015-16497
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number351.16J
Device LOT Number8053605
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2012
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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