MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgical procedure it was observed that, the expressew iii ac+ gun device was, catching and was unable to pull the suture through the rotator cuff, causing the surgeon to remove the device and start over.It was reported that another device was used to complete the surgery.It was reported that there was a slight delay in the procedure due to the event.There were no adverse consequences to the patient.No additional information could be provided.
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 has not returned to depuy synthes; however, photos were provided for evaluation.Visual inspection of the returned photos found no observations pertaining to the nature, of the reported event or any other anomaly.The overall complaint was not confirmed as the observed condition of the expressew iii, ac+ gun would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential, cause about the reported event can be established due to the insufficient evidence, provided.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.
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 returned to depuy synthes for evaluation.Visual inspection of the returned device found it was returned in used condition.The suture, the needle and the retention plate were not returned for evaluation.No other anomalies were noted.A functional test was performed by activation of the device.Using a sample rotator cuff simulator, test suture and test needle, the device trigger was pressed, and the needle deployed and functioned as expected.The overall complaint was not confirmed as the observed condition of the expressew iii ac+ gun would have not contributed to the complained device issue.¿ based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence provided.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.
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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

• Brand Name: EXPRESSEW III AC+ GUN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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 02400 ; 9083863534
• MDR Report Key: 24004756
• Report Number: 1221934-2026-00122
• Device Sequence Number: 9406437
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: (01)10886705027101(10)6787122082207
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 288233
• Device Lot Number: 6787122082207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 01/28/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/27/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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