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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.034S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting. Device malfunctioned intra-operatively and was not implanted / explanted. Initial reporter telephone not available for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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 proximal femoral nail antirotation (pfna) surgery on (b)(6) 2018, when inserting the blade, the impactor for pfna blade broke. The blade became stuck in the impactor along with the guide wire. The guide wire remains in the impactor. There was another device readily available and was used to complete the procedure successfully with a delay of approximately 5 minutes. Patient outcome reported as successful. This report is for one (1) pfna blade. This is report 2 of 2 for (b)(4).
 
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Brand NamePFNA BLADE PERF L95 TAN
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 Key7601512
MDR Text Key111204817
Report Number8030965-2018-54337
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFI
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 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.034S
Device Lot NumberL820687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2018
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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