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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 85MM ¿ STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 85MM ¿ STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.385S
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent am open reduction internal fixation (orif) surgery for trochanteric fracture of femur with the trochanteric fixation nail advanced (tfna) implants. After the surgery, telescoping of the blade occurred on an unknown date. The nail interferes with the bone, resulting in varus. The blade came out about five millimeters (5 mm). Reoperation is planned on an unknown date. The tnfa implants will be removed, and an intramedullary nail or artificial bone head will be implanted. The surgeon commented that the reduction position during surgery, bone quality, and placement position of the implant were affected. No further information is available. This report is for a tfna nail. This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is a synthes employee. Part 04. 038. 385s, lot 346p216: manufacturing location: (b)(4), packaged, sterilized and released by: (b)(4). Manufacturing date: august 27, 2021. Expiration date: august 01, 2031. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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.
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 85MM ¿ 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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14075138
MDR Text Key289013412
Report Number8030965-2022-02358
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.385S
Device Lot Number346P216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/11/2022 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L36 F/NAILS TAN; TFNA FEM NAIL Ø11 LE 130° L235 TIMO15
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