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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH IMPACTOR F/PFNA BLADE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.010.410
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Additional narrative: date of event is unknown. Device is an instrument and is not implanted/explanted. (b)(6). Device is not distributed in the united states. Subject device has been received and is currently in the evaluation process. Part number: 03. 010. 410, synthes lot number: 9419710: release to warehouse date: may 18, 2015. Mfg. Site: (b)(4). No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes europe reports an event in (b)(6) is as follows; it was reported that the blue plastic handle is loose from shaft of an impactor for proximal femoral nail antirotation (pfna) blade. The welding seam broke at the proximal end. It is unknown when the issue occurred, but there was no patient involvement. This is report number 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: a manufacturing investigation action was performed. The report indicates that: the manufacturing documents were reviewed and no complaint related issues were found. The present failure mode is already addressed, which did result in field action, product removal. Therefore no further evaluation on this complaint is needed. The preliminary cause was identified as a design issue of the welding of the impactor (weld is not resistant to support hammering operations). Device 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 NameIMPACTOR F/PFNA BLADE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key6159316
MDR Text Key62350937
Report Number9612488-2016-10502
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.410
Device Lot Number9419710
Other Device ID Number(01)07611819349476(10)9419710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/18/2015
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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