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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.052S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting. Device malfunctioned intra-operatively and was not implanted / explanted. (b)(6). 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 surgeon was implanting the proximal femoral nail antirotation (pfna) ii system on unknown date. Surgeon was not able to lock the pfna blade due to lack of compression. Surgery was completed successfully with a delay of approximately 45 minutes and no harm to patient. This report is for one (1) pfna ii blade. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
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
During manufacturer¿s preliminary analysis of the returned devices it was observed that a broken off bit is stuck in the blade. This is report 1 of 2 for complaint (b)(4).
 
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Brand NamePFNA-II BLADE L85 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7567509
MDR Text Key110034759
Report Number8030965-2018-54115
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.052S
Device Lot NumberL292672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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