MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90 - SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	04.038.390S
Medical Device Problem Codes	Material Twisted/Bent (2981); Migration (4003)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Bone Notching (4890)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h6: health effect clinical code e2015 captures bone notching.
Event or Problem Description
It was reported that when doing a tfna, the helical blade was attached to the inserter by the tech and checked by the surgeon.The blade was implanted, once implantation was complete the blade was through the femoral head.It seemed when connecting the helical blade, the connecting screw wasn¿t fully screwed down (cross threaded into the helical blade), so when the implant was malleted in the helical blade advanced partially off the inserter and through the femoral head.The helical blade was then backed out into corrected seated position inside the femoral head and in the nail.The case was completed with a 10-15 minute delay.
Additional 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.H11 additional narrative: added: a2 (dob, age), a3a, b5, d10 (concomitant), e1 (facility name), h6 (medical device problem code).Corrected: h6 (health effect - clinical code).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that the inserter worked fine after the case.It seems the inserter and helical blade go cross threaded on the inserter.
Additional 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.H11 additional narrative: device history review: manufacturing location: elmira / packaged, sterilized and released by: monument manufacturing date: 14-aug-2023.Expiration date: 30-jun-2033.Part number: 04.038.390s, tfna fenestrated helical blade 90mm -sterile.Lot number: 7323p99 (sterile).Lot quantity: (b)(4).Review of the dhr file: helical blade was manufactured by elmira; lot numbers 3491p70 quantity (b)(4) and 3516p12 quantity (b)(4).Parts were packaged, sterilized, and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll), lppf rev g, lmd rev b were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 26317 supplied by sterigenics was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 7323p99.No nonconformities or manufacturing irregularities have identified related to the complaint condition.15-may-2025: dhr reviewed : a manufacturing record evaluation was performed for the finished device with batch number 7323p99.No nonconformities or manufacturing irregularities have identified related to the complaint condition.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 90 - SILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22104116
• Report Number: 8030965-2025-05282
• Device Sequence Number: 7276597
• Product Code: KTT
• UDI-Device Identifier: 10886982099259
• UDI-Public: (01)10886982099259(17)330630(10)7323P99
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.390S
• Device Lot Number: 7323P99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 06/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/02/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: TRAUMA.
• Patient Age: 70 YR
• Patient Sex: Female