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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.026S
Device Problem Failure to Align (2522)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
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 as no product was received. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, an osteosynthesis with long trochanteric femoral nailing advanced (tfna) system was applied to surgery for femoral subtrochanteric fracture in which the great trochanter cracked longitudinally. Upon final checking using the image, it was noticed that the tfna helical blade had been positioned out of bounds. Initially, after deciding the insertion point of the blade, a guide wire was inserted and was confirmed to be inserted at the center of the femoral head by anterior-posterior (ap), and medial-lateral (ml) images. Then, a helical blade in question was inserted, the side stopping was done and an end cap was inserted. However, when the final check was done, it was noticed that the blade had been positioned out of bounds. The blade and the end cap were removed and the locking mechanism was released. After the insertion handle was re-connected, a guide wire was inserted followed by the insertion of the helical blade. The surgeon confirmed that the helical blade was properly positioned in the femoral head, then the surgical wound was closed. The surgery was successfully completed and was delayed by 60 minutes. There was no adverse consequence to the patient. Concomitant devices reported: tfna end cap (part# 04. 038. 000s, lot# 2l79397, quantity 1), locking screw (part# 04. 005. 534s, lot# l971780, quantity 1), locking screw (part# 04. 005. 530s, lot# l998222, quantity 1), unknown guide wire (part# unknown, lot# unknown, quantity 1). This complaint involves two (2) devices. This report is for one (1) 10mm/125 deg ti cann tfna 360mm/right - sterile. This report is 2 of 2 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8734737
MDR Text Key149220210
Report Number8030965-2019-65733
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
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 05/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.026S
Device Lot NumberH690076
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 Received08/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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