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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.055S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 08/25/2018
Event Type  Injury  
Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 the patient underwent proximal femoral nail antirotation (pfna-ii) surgery on (b)(6) 2018. When the surgeon inserted the 100mm helical blade in the femur neck, the blade would not lock. After two to three attempts, the surgeon removed the blade and replaced it with a 95mm blade which the surgeon also found difficult to lock. The surgeon has completed approximately 250 pfna-ii cases and this is the first time he has encountered any issues. It is unknown if there was any surgical delay. Procedure and patient outcome are unknown. Concomitant device reported: unknown pfna nail (part# unknown, lot# unknown, quantity# 1). This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L100 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 19380
6103142063
MDR Report Key7877197
MDR Text Key120292436
Report Number8030965-2018-56349
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
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 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.055S
Device Lot NumberL847708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2018
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: 09/14/2018 Patient Sequence Number: 1
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