MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM RADIOLUCENT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.233.006
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
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.
Event or Problem Description
It was reported on (b)(6) 2026, that surgeon was inserting the retrograde nail into the femoral canal.The aiming arm was connected to the insertion handle during nail insertion.Their was a tight fit of the nail in the femoral canal that required force when delivering the mallet on the driving cap.During impaction, the mechanism that attaches the aiming arm to the insertion handle was knocked loose, causing the aiming arm to permanently disconnect from the insertion handle.They have two instrument sets and a second set was opened and successfully utilized.The delay in the case was minimal, only requiring the time to locate and open the second instrument set.The case was successfully completed.The broken aiming arm needs replaced asap.

• Brand Name: AIMING ARM RADIOLUCENT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25390899
• Report Number: 8030965-2026-05135
• Device Sequence Number: 10672263
• Product Code: HSB
• UDI-Device Identifier: 10886982288363
• UDI-Public: (01)10886982288363(10)84P0575
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• 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,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: 03.233.006
• Device Lot Number: 84P0575
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2021
• 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