MAUDE Adverse Event Report: Medos International SÃ rl EXPRESSEW; Orthopedic Manual Surgical Instrument

Catalog Number	288235
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, when performing the first suturing step in tissue with the exprsew iii ac+ rtn plate device, the plate did not properly hold the suture.A second attempt was made and the plate released the thread.On inspection, the plate tip was slightly raised and therefore did not retain the thread.The specialist used another retaining plate, which worked properly.There were no delays to the surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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.H11: additional narrative: investigation summary: the product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection of the returned photo reveled that the device is shown in used condition.The auto-capture plate is slightly bent upwards.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the exprsew iii ac+ rtn plate 1ea would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to bad positioning during installation on the expressew jaw therefore the plate was bent and not properly seated into the jaw.As per instructions for use (ifu); while maintaining the loading tool in a flat position (do not angle or rotate), slide the loading tool forward until it stops.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.Device history review: a manufacturing record evaluation was performed for the finished device lot number (78217), and no non-conformance was identified.

• Brand Name: EXPRESSEW
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): Medos International SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Medos International SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50718037
• Report Number: 1221934-2026-04072
• Device Sequence Number: 21492857
• Product Code: LXH
• UDI-Device Identifier: 10886705027125
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 288235
• Device Lot Number: 78217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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