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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hypovolemic Shock (1917)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown tfn nail/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device was not reported to have been explanted. Complainant part is not expected to be returned for manufacturer review/investigation. 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 (b)(4) reports an event in (b)(6) as follows: it was reported patient presented on an unknown date with transtrochanteric fracture and multiple unidentified comorbidities which required rapid surgical intervention. A trochanteric fixation nail advanced (tfna) procedure was scheduled. It is unknown when it was discovered that there were no tfnas available. It was then decided to use the trochanteric fixation nail (tfn) product. During the tfn procedure, surgeon attempted multiple times to insert the helical blade but was not successful. It was then noted the tfn nail¿s locking mechanism was pre-deployed. Surgeon removed the nail and backed out the locking mechanism, then re-inserted the nail and was then able to insert the helical blade. Patient experienced blood loss and was reported to have gone into shock. Surgery was completed with a delay of approximately two and one half (2 ½) hours. Concomitant device reported: tfn helical blade (part number unknown, lot number unknown, quantity 1).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7421185
MDR Text Key105147336
Report Number8030965-2018-52973
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received01/17/2018
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

Patient Treatment Data
Date Received: 04/11/2018 Patient Sequence Number: 1
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