MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L90 TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	04.038.390S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Notching (4890)
Type of Reportable Event	Malfunction
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, 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.Device history lot = > manufacturing location: elmira / packaged, sterilized and released by: monument manufacturing date: 31-jan-2025 expiration date: 01-jan-2035 part number: 04.038.390s, tfna fenestrated helical blade 90mm -sterile lot number: 49892p2 (sterile) lot quantity: 96 review of the dhr file: helical blade was manufactured by elmira; lot numbers 48367p0 quantity 96.Parts were packaged, sterilized, and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll), lmd rev ac was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 30757 supplied by sterigenics was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 49892p2.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Device history review = > this lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A manufacturing record evaluation was performed for the finished device with batch number 49892p2.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent unknown surgery.The surgery was completed successfully with no surgical delay.It appears that excessive compression had been applied during the initial surgery and stress had been put on the lateral wall, causing it to crack.The affected area appears to have become more unstable since the initial surgery.The locking mechanism had also been set in a sliding position, which resulted in a bone-to-nail situation, with the blade moving in the direction of cutting out.The treatment plan is that the dislocation does not appear to have progressed over the past week from the alert date, so the surgeon will monitor the situation with teriparatide for two weeks.

• Brand Name: TFNA HELICAL BLADE PERF L90 TAN
• Common Device Name: 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: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22160257
• Report Number: 8030965-2025-05698
• Device Sequence Number: 12638941
• Product Code: KTT
• UDI-Device Identifier: 10886982099259
• UDI-Public: (01)10886982099259(17)350101(10)49892P2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 49892P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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
• Patient Sex: Unknown