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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.115S
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Device report from australia reports an event as follows: it was reported that patient was treated on (b)(6) 2020, for nof fracture with a trochanteric fixation nail advanced (tfna) 235mm nail, blade, and was augmented with traumacem.On (b)(6) 2021, the patient presented to clinic with progressive lateral thigh pain which had increased over the last twelve months.Upon imaging, the initial nof fracture appears to be healed but the tfna nail had fractured at the proximal aperture and the blade had migrated laterally.As of (b)(6) 2022, the patient still had lateral thigh pain but did not want further operations to remove the implants.This report is for a 11mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 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.(b)(6).Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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
11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14714667
MDR Text Key294946673
Report Number8030965-2022-04075
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819650299
UDI-Public(01)07611819650299
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160167
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.037.115S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2022
Initial Date FDA Received06/16/2022
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
TFNA HELICAL BLADE PERF L90 TAN; TRAUMACEM V+ CEMENT KIT 10 ML
Patient Outcome(s) Required Intervention;
Patient SexFemale
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