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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.054S
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event is an unknown date in 2019. Reporter is a synthes employee. 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. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 (b)(6) reports an event as follows: it was reported that during surgery on an unknown date, the proximal femoral nail antirotation (pfna) blade couldn¿t compress. Procedure outcome and patient status are unknown. Concomitant devices: insertion instrument (part: unknown, lot: unknown, quantity: 1), compression instrument (part: unknown, lot: unknown, quantity: 1); compression nut (part: unknown, lot: unknown, quantity: 1). This report is for a pfna blade. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8950364
MDR Text Key156347819
Report Number8030965-2019-67877
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTW
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
Report Date 08/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot Number4L36835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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