MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL EXPRESSEW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288235
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
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.The complaint device was discarded by the customer, therefore not returned to depuy synthes and unavailable for a physical evaluation.Given that no lot/serial number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot/serial number becomes available, the mre review will be performed.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair (arcr) surgical procedure, the exprsew iii ac+ rtn plate 1ea could not be attached to autocaputure even though it was used in a normal way.The surgery was completed with no issues using new implant.There was no surgical delay and no harm to the patient.The device was brand new and the first use when the issue occurred.No further information is available.

• 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 SÃ RL; chemin-blanc 38; le locle ; SZ
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25615640
• Report Number: 1221934-2026-02781
• Device Sequence Number: 16001213
• Product Code: LXH
• UDI-Device Identifier: 10886705027125
• UDI-Public: (01)10886705027125(10)
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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