MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL EXPRESSEW III AC+ GUN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288233
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.E1: the reporter¿s complete facility address was not provided.According to the information received, it was reported that the surgeon used the products as usual but was unable to catch the thread due to poor bite alignment.It was thought that there may have been a problem with the autocapture unit itself.There was no surgical delay and no harm to the patient.The device was brand new and the first use when the issue occurred.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition as expected in reusable devices.The upper jaw was found slightly bent at the tip, which can cause autocapture issues during use.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the expressew iii ac+ gun would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to hard and continuous use; since this device is reusable, the continuous use and sterilization process can cause metal fatigue leading to bent upper jaw, however, this cannot be conclusively determined.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.A manufacturing record evaluation was performed for the finished device 5145019031805 number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure that the surgeon used the expressew iii ac+ gun as usual but was unable to catch the thread due to poor bite alignment.It was thought that there may have been a problem with the autocapture unit itself.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.

• Brand Name: EXPRESSEW III AC+ GUN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24445687
• Report Number: 1221934-2026-00892
• Device Sequence Number: 21444762
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: (01)10886705027101(10)5145019031805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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: 288233
• Device Lot Number: 5145019031805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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