MAUDE Adverse Event Report: Synthes GmbH AIMING ARM/ RADIOLUCENT; NAIL, FIXATION, BONE

Catalog Number	03.043.029
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date that they were writing to report an issue with the aiming arm they have in one of our four tibia nail advanced sets.They have used the aiming arm on the three separate occasions with issues using both the hybrid insertion handle and the stainless steel insertion handle.On all three occasions that they are reporting, it has missed the proximal static hole when they go to drill, which is causing a great deal of frustration with our surgeons.They are unsure of what else could be causing this issue at this point as we have also replaced the steel insertion handle, and all other sets seem to be okay.
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.

• 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): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50895756
• Report Number: 8030965-2026-09762
• Device Sequence Number: 20296683
• Product Code: JDS
• UDI-Device Identifier: 10886982297396
• UDI-Public: (01)10886982297396(10)2031642
• 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
• 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: 2031642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown