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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø9 LONG LE 130° L360 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø9 LONG LE 130° L360 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.187S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. 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. (b)(4). 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 a patient had two (2) pfna nail implants (left and right femurs) to treat a pathologic fracture. The right (9mm) pfna nail was implanted on (b)(6) 2018. On an unknown date, the patient was getting out of a chair and the left pfna nail broke. The patient underwent a revision procedure on (b)(6) 2018. During revision, all fragments from the broken nail were removed and a 10mm pfna nail was implanted in the right femur. It was unknown if there was a surgical delay. Patient outcome was unknown. Concomitant devices: pfna blade (part unknown, lot unknown, quantity 1), locking screws (part unknown, lot unknown, quantity unknown). This report is for one (1) pfna nail this is report 1 of 1 for (b)(4).
 
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Brand NamePFNA Ø9 LONG LE 130° L360 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 Key8141189
MDR Text Key129573706
Report Number8030965-2018-58815
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
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,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.187S
Device Lot NumberL383168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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