MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 95MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.038.395S

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem Pain (1994)

Event Date 12/14/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent an open reduction internal fixation procedure with the tfna for a femoral proximal fracture on (b)(6) 2023.The tfna long nail was used for reverse case.On december 14, 2023, the patient complained of pain.It was confirmed that internal deformation occurred and caused cut-through.On (b)(6) 2023, a revision surgery was performed, and the 10mm long nail was replaced with a 12mm nail.The buttress plate was additionally fixed slightly posterior to the lateral proximal area.The revision was completed successfully without any delay.According to the surgeon, poor reduction and lack of fixation strength caused cut-through.The patient outcome was reported to be stable.This report involves one tfna fenestrated helical blade 95mm - sterile.This is report 1 of 1 for pc-001508910.

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: hsb.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name: (b)(6) hospital.H3, h4, h6: 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 history review (dhr): manufacturing location: elmira / packaged, sterilized and released by: monument, manufacturing date: 01-jan-2023, expiration date: 01-dec-2032, part number: 04.038.395s, tfna fenestrated helical blade 95mm -sterile, lot number: 3798p67 (sterile), lot quantity: (b)(4).Note: helical blade was manufactured by elmira; lot numbers 3516p14, qty (b)(4), and 3626p16, qty (b)(4).Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll)was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM - STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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 Key: 18502388
• MDR Text Key: 332768923
• Report Number: 8030965-2024-00768
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819652583
• UDI-Public: (01)07611819652583
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• 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 Number: 04.038.395S
• Device Lot Number: 3798P67
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: TFNA; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male