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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.390S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Patient height reported as 158cm. Date of event is an unknown date in 2022. Additional procode: ktt. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Additional concomitant device: 2x unknown cable cerclage. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) reports an event as follows: it was reported that during a meeting of the aotc held on (b)(6) 2021, slides were presented which represented four tfna cases with medial blade migration into the pelvic area. All four cases were revised to a prosthesis. This captures the case with patient: female, (b)(6) at time of event. Patient began to complain of pain on (b)(6) 2022. This report is for a tfna fenestrated helical blade 90mm - sterile. This is report 1 of 1 for (b)(4). Additional reports are captured under (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 90MM - STERILE
Type of DeviceROD, 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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13666786
MDR Text Key291486153
Report Number8030965-2022-01365
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.390S
Device Catalogue Number04.038.390S
Device Lot Number492P023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
Treatment
LOCKSCR 5 L28 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø10 130° L200 TIMO15
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