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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT A2FN NAIL ¿9 LE CANN L340 TAN LIG ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT A2FN NAIL ¿9 LE CANN L340 TAN LIG ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.249S
Device Problem Dull, Blunt (2407)
Patient Problem No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
Patient¿s identifier, date of birth and weight are unknown. Device remained implanted in the patient; as such explant date is not applicable. Complainant device is not expected to be returned for manufacturer review/investigation. Reporter phone number and address is not provided for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4) is used to capture the surgical intervention: the incision was enlarged and unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay 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 that a surgery for femoral diaphyseal fracture was performed on (b)(6) 2017. After the nail and some screws were inserted, the surgeon could not fix the end cap 10 mm to the nail. In addition to the main surgeon, three other surgeons took turns to correct this difficulty with the following countermeasures, which did not succeed: repositioning of the patient¿s body, enlarging the incision area, lightly hitting to the driver for inserting end cap with a hammer, replacing with end cap 5 mm and end cap 0 mm. Finally, unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay. There was no adverse consequence to the teenage patient. The surgeon commented that hammering might have damaged threads of the nail. Procedure was completed successfully. Concomitant device reported: unknown hammer/mallet (part # unknown, lot # unknown, quantity 1). This report is for one (1) expert a2fn nail 9 le cann l340 tan lig. This is report 4 of 4 for (b)(4).
 
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Brand NameEXPERT A2FN NAIL ¿9 LE CANN L340 TAN LIG
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7165875
MDR Text Key96449241
Report Number8030965-2018-50089
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 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.249S
Device Lot Number7931184
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 Received03/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2012
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: 01/04/2018 Patient Sequence Number: 1
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