MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM LOCKING DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.037.015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent an orthopedic procedure on (b)(6) 2025.The sleeve kept getting stuck in the aiming arm locking device; did not slide in properly.Procedure was completed successfully with no delay.There was no patient consequence.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: d4 (lot), d9 corrected: d4 (primary udi #) the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: h4.Corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the lock-insert f/aim arm.There is only a stain, like dried water, on the surface where the product information is engraved.Refer device/country specific ifu for information related to cleaning, sterilization, reprocessing instructions, and inspection procedures.A dimensional inspection was performed for the lock-insert f/aim arm and met specifications.A functional test was performed using a sample product code 03.037.013 and the lock-insert was able to connect properly.The complaint condition was not able to be replicated.The overall complaint was not confirmed as the observed condition of the lock-insert f/aim arm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: drawing: se_434572 rev.H (manufactured), feature: width, specification: 28.45 +0.0 / -0.1 mm, measured dimension: 28.43 mm (conforming), device used: mitutoyo digimatic caliper (b)(6) id# (b)(6).Device history review: lot number 91p5452 in the dhr review is from the component 60082593 which is used in the finish level article 03.037.013-us.Dhr review is performed for the component level lot 91p5452 and also for the finish level article 03.037.013-us lot where the component lot is used.Part number: 60082593, 03.037.013-us, lot number: 91p5452 (24 pc, 60082593), 97p8249 (12 pc) / 97p8245 (12 pc) - 03.037.031-us manufacturing site: hägendorf release to warehouse date: 25-mar-2021 (91p5452), 26-april-2021 (97p8249), 23-april-2021 (97p8245) a manufacturing record evaluation was performed for the finished device batch number, 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.

• Brand Name: AIMING ARM LOCKING DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23019859
• Report Number: 8030965-2025-09168
• Device Sequence Number: 9769529
• Product Code: LXH
• UDI-Device Identifier: 07611819642416
• UDI-Public: (01)07611819642416(10)91P5452
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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,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: 03.037.015
• Device Lot Number: 91P5452
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 03/10/2026; 03/26/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/11/2025; 03/13/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown