MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM/ RADIOLUCENT; NAIL, FIXATION, BONE

Catalog Number	03.043.029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation of " 03.043.029, aim-arm radioluc" revealed that the latch was broken.These forces may prevent accurate targeting through proximal locking holes and damage the drill bits.Note: the proximal ap screw is inserted through the guiding hole in the insertion handle and does not require aiming arm to be attached.Assemble the three-part trocar assembly (protection sleeve, drill sleeve, and trocar).Align the triangular marking at the tip of the protection sleeve with the marking beside the desired hole on the aiming arm, and insert the three-part trocar assembly through the aiming arm.Make a stab incision and insert the trocar to the bone.Twist the protection sleeve by a quarter turn to lock it into place.Remove the trocar.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the aim-arm radioluc would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to cause not established, and 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 depuy synthes 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: part # 03.043.029.Lot # 2024221.Release to warehouse date: 09.Apr.2021.Manufacturing site: selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.
Event or Problem Description
It was reported on (b)(6) 2026 the surgeon was inserting a tibia nail.The nail was inserted and the jig was then hooked onto the nail insertor.When the aiming arm was clicked onto the jig the latch broke.No patient harm was created and we opened another set to complete the procedure.No patient harm.

• Brand Name: AIMING ARM/ RADIOLUCENT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24691899
• Report Number: 8030965-2026-02821
• Device Sequence Number: 9727006
• Product Code: JDS
• UDI-Device Identifier: 10886982297396
• UDI-Public: (01)10886982297396(10)2024221
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 03.043.029
• Device Lot Number: 2024221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• 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