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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE; NAIL, FIXATION, BONE

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SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE; NAIL, FIXATION, BONE Back to Search Results
Model Number 04.043.340S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
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.D2: additional procode: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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
Subject: (b)(6).Adverse event term: nonunion.Is this a worsening of an existing event? no.Site awareness date: 06-04-2023.Type of event: local/fracture site.Side: left.Device: tna.Severity: moderate.Is the adverse event serious? yes.This report is for a tibial nail-advanced / 11mm 360mm / sterile.This is report 1 of 7 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 360MM / 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 
3035526892
MDR Report Key16863180
MDR Text Key314495553
Report Number8030965-2023-05662
Device Sequence Number1
Product Code JDS
UDI-Device Identifier10886982298249
UDI-Public(01)10886982298249
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
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 Model Number04.043.340S
Device Catalogue Number04.043.340S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2023
Initial Date FDA Received05/03/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received05/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexMale
Patient Weight99 KG
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