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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 12MM 330MM / STERILE; NAIL, FIXATION, BONE

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SYNTHES GMBH TIBIAL NAIL-ADVANCED / 12MM 330MM / STERILE; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 04.043.430S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
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: d2b additional device product codes: hwc.D10 therapy date: (b)(6) 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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.
 
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the surgery with the tna in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient had infection.On (b)(6) 2023, the tna was removed to clean the infected area.The removal surgery was completed successfully without any surgical delay.This report involves one (1) tibial nail-advanced / 12mm 330mm / sterile.This is report 1 of 3 for (b)(4).
 
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Brand Name
TIBIAL NAIL-ADVANCED / 12MM 330MM / 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 Key16797432
MDR Text Key313846288
Report Number8030965-2023-05181
Device Sequence Number1
Product Code JDS
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 Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.043.430S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received04/24/2023
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
UNK - NAIL HEAD ELEMENTS; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
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