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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 Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown nail head elements: dhs/ dcs blade/ unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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
It was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with the lcp dhs plate in question. During the surgery, the surgeon inserted the blade (length 70mm). The surgeon originally had to use a plate with shorter barrel, but she used the plate with the standard barrel. The plate was fixed, but the distance between the blade part and the barrel part was shorter than usual, because the surgeon used the standard barrel plate. The fracture was atypical, and there was a gap (about 1-2mm long) around the femur calcar. The surgeon commented that the cut-out will not occur because the plate will hardly slide. There was no surgical delay. No further information is available. This complaint involves two (2) devices. This report is for one (1) unk - nail head elements: dhs/ dcs blade. This report is 2 of 2 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9120900
MDR Text Key192386110
Report Number8030965-2019-68712
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
Report Date 08/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
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 Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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