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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting. Due to the intra-operative events,it is unknown if the device was successfully implanted. (b)(6). The (510k):unknown device is not distributed in the united states, but is similar to device marketed in the usa. 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)(4) as follows: it was reported that a proximal femoral nail antirotion (pfna-ii) blade cannot lock during an unknown orthopaedic procedure on (b)(6) 2018. It is unknown if there was a surgical delay. Patient and surgical outcome is unknown. Concomitant device: unknown pfna-ii nail (part#unknown, lot#unknown, quantity#unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: corrected data: 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.
 
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Brand NamePFNA-II BLADE L90 TAN
Type of DeviceROD, FIXATION INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7868506
MDR Text Key119956368
Report Number8030965-2018-56238
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,Followup
Report Date 08/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.053S
Device Lot NumberL859632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Is This a Reprocessed and Reused Single-Use Device?

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