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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L100 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH PFNA BLADE PERF L100 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.035S
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A product development investigation was performed for the subject device. The present articles (impactor f/pfna blade and pfna blade perf l100 tan ) were checked. Manufacturing and inspection records indicated no problem with the lot in question. The investigation has shown that the pfna blade is jammed on the impactor. Further investigation has shown that on the surface of the pfna blade are visible strong marks. At the head end of the impactor there are strong impact marks visible, the welding between handle and shaft is broken and also a part of blue handle is blow out. Based on these findings we have to assume that excessive strokes on the impactor have caused the breakage of the welding seam and the jammed pfna blade. We can not remove the pfna blade from the impactor. We have to assume that there were a handling fault. The pfna blade were not properly screwed on the impactor as a result of excessive hammer blows jammed the connection between blade and impactor. Report was initially submitted on october 27, 2017 but the fda site was down. Advised by fda on november 06, 2017 to resubmit medwatch. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Patient information is not available for reporting. Date of event is unknown. Udi: (b)(4) lot number unknown device is not implanted/explanted. Reporter phone number: (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number, the device history record review could not be requested. The device has been received and the product evaluation is in progress. No conclusion can be drawn. 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a surgery it was not possible to remove the proximal femoral nail antirotation (pfna) blade from the impactor for the pfna blade. The surgery was prolonged for about five (5) minutes. There was no patient harm. This report is for one (1) pfna blade. This is report 2 of 2 for complaint (b)(4).
 
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Brand NamePFNA BLADE PERF L100 TAN
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 Key6810118
MDR Text Key254264766
Report Number9612488-2017-10424
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.035S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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