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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 SST ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 SST ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 02.027.033S
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is unknown. Unknown date in (b)(6) 2018. This report is for an unknown pfna blade /unknown lot. Part and lot number are unknown; udi number is unknown. It is unknown if the device was implant/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter phone number and email address were not provided. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 surgery the blade could not be connected/detached with the impactor. There were no consequences for the patient. This report is for an unknown proximal femoral nail anti-rotation (pfna) blade. This is report 2 of 2 for (b)(4).
 
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Brand NamePFNA BLADE PERF L90 SST
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7638298
MDR Text Key112849367
Report Number8030965-2018-54636
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.027.033S
Device Lot NumberL846665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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