MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM 125° F/STAT+DYN DIST LOCK; GUIDE

Catalog Number	03.037.114
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2024, the patient underwent orif surgery via tfna for femoral intertrochanteric fracture on femur with the products in question.After the surgery, the surgeon informed the defect.In the surgery, when drilling the outer cortex before blade insertion, there was a sensation of interference with the nail, but drilled a little harder with several reverse rotations.The drill tip passed through the nail and proceeded to insert the blade, but only halfway through due to interference with the nail.Once the nail was removed and checked, the nail was found to have been scraped.The shaved nail was not used, a different size nail (125° 9mm extra short) was used, and the blade was inserted in a near freehand manner without sleeves of any kind.After that, the set screw was tightened without any problem, and a 130° aiming arm was used for the distal lateral stop.There were no problems with fixation.The surgery was completed successfully with 30 minutes surgical delay.No further information is available.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: d9 h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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: b5 corrected: g1 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: the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned sample revealed that there were no signs of damage or defect with the aim-arm 125° f/stat+dyn dist lock.A dimensional inspection was not performed since it was not applicable to the complaint condition.A full functional test was unable to be performed due to the complete tfn-advanced proximal femoral nailing system devices were not returned.However, a partial functional test was performed with mating devices also returned in this complaint.The devices used are: 03.037.017 guide sleeve yell and 03.037.016 buttress/compr-nut.The mating devices could not be assembly correctly due to the condition of the 03.037.017 guide sleeve.However, the functional test was performed again with an external mating device 03.037.017 guide sleeve and the mating devices entered in the hole of the 125 deg aiming arm static+dynamic and assembled as expected.Once assembled the 03.037.016 buttress/compr-nut was activated and functioned as desired.This test was performed multiple times without noticing any signs of resistance that would prevent the device from functioning.Therefore, based on the visual and functional analysis of the device, the customer allegation cannot be confirmed.The overall complaint was not confirmed as the observed condition of the aim-arm 125° f/stat+dyn dist lock would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > part:03.037.114 lot:9771066 manufacturing site: werk hagendorf supplier: na release to warehouse date:08 feb 2016 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 there are no pieces in the patient.The surgeon confirmed by x-ray.

• Brand Name: AIM-ARM 125° F/STAT+DYN DIST LOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20914644
• Report Number: 8030965-2024-14923
• Device Sequence Number: 20977809
• Product Code: FZX
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676(10)9771066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 12/12/2024

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: 03.037.114
• Device Lot Number: 9771066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 01/17/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/07/2025; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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