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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 300MM / STERILE; NAIL, FIXATION, BONE

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SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 300MM / STERILE; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 04.043.320S
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem Insufficient Information (4580)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on november 29, 2023, the patient underwent surgery for a tibial diaphyseal fracture with the tna.In the surgery, the drill tip in question interfered with the nail when drilling the ap hole during fixation of the distal lateral stop screw.It is possible that the inlay was slightly shaved off in doing so.The direction of the drill tip was changed, drilling was performed again, and the screw insertion was successfully completed.The surgeon confirmed that there were no pieces in the patient¿s body.This report involves one tibial nail-advanced / 11mm 300mm / sterile.This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
 
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Brand Name
TIBIAL NAIL-ADVANCED / 11MM 300MM / STERILE
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ   2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18372050
MDR Text Key331378231
Report Number8030965-2023-16012
Device Sequence Number1
Product Code JDS
UDI-Device Identifier07612334171641
UDI-Public(01)07612334171641
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.043.320S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP; UNK - SCREWS: TRAUMA
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