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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.010.410
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Facility address not available for reporting. 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. 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)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) for a femoral trochanteric fracture, utilizing the proximal femoral nail antirotation (pfna) on (b)(6) 2018. After the pfna blade was inserted it was locked to the nail. However, the pfna impactor did not detach from the pfna blade and the blade was removed. Surgeon re-inserted the blade, fixed it in the usual manner, then detached the impactor. Surgery was completed successfully with a delay of approximately 30 minutes. No adverse consequence to the patient was reported. This report is for one (1) impactor for pfna blade. This is report 1 of 2 for (b)(4).
 
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Brand NameIMPACTOR F/PFNA BLADE
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7400307
MDR Text Key104583232
Report Number8030965-2018-52798
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.410
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 Received05/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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