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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1FNA Ø10 LONG LE 130° L340 TAN ROD, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 1FNA Ø10 LONG LE 130° L340 TAN ROD, FIXATION, BONE Back to Search Results
Catalog Number 472.325S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event reported as 2018, exact date is not known. 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. Without a lot number the device history records review could not be completed. Product was not returned. 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 synthes europe reports an event in (b)(6) as follows: it was reported that patient was implanted with a proximal femoral nail antirotation (pfna) nail and two (2) bolts on (b)(6) 2018. On unknown date it was revealed that the nail and two (2) bolts were broken. This report is for one (1) pfna nail. This is report 1 of 3 for (b)(4).
 
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Brand Name1FNA Ø10 LONG LE 130° L340 TAN
Type of DeviceROD, FIXATION, BONE
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 Key8141582
MDR Text Key129593810
Report Number8030965-2018-58821
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819293168
UDI-Public(01)07611819293168
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/14/2018
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 Number472.325S
Device Lot NumberL411556
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
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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