MAUDE Adverse Event Report: Synthes GmbH Aim-Arm radioluc; Rod, Fixation, Intramedullary and Accessories

Catalog Number	03.233.006
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a piece of the device was lost in sterilization process of rfna aiming arm.Product cannot be used without it.No patient involvement.
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary.The product was returned to depuy synthes for evaluation.¿visual inspection of the returned device revealed damage to the aiming arm - center part and the latch, both of which were found broken.Additionally, the pin was separated from the device as a result of the damage observed in this area of the product.All device components were returned and available for evaluation.¿ the rfn-advanced retrograde femoral nailing system, was reviewed.Following relevant statements were found at page 24.Attach the aiming arm to the insertion handle, by sliding it into the hook at the distal part of the insertion handle and then rotating the latch towards the insertion handle for both parts to connect.Precaution: do not exert forces on the aiming arm, protection sleeve, drill sleeves and drill bits.These forces may prevent.Accurate targeting through proximal locking holes and damage the drill bits.A dimensional inspection was unable to be performed due to post manufacturing damage.¿a functional evaluation was unable to be performed due to post manufacturing damage.¿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, 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 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.¿ dimensional inspection: n/a.Device history.Per franchise complaint product investigation procedure complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.

• Brand Name: Aim-Arm radioluc
• Common Device Name: Rod, Fixation, Intramedullary and Accessories
• 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: 50503352
• Report Number: 8030965-2026-08640
• Device Sequence Number: 9431385
• Product Code: HSB
• UDI-Device Identifier: 10886982288363
• UDI-Public: (01)10886982288363(10)614P568
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• 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: 03.233.006
• Device Lot Number: 614P568
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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