MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228147
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
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.H11 additional narrative: e1: the reporter¿s complete facility address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a rotator cuff repair surgical procedure, while using a 4.5 healix advance br w/ocord anchor device it was observed that the anchor was broken off.It was reported that all broken parts were removed.It was reported that another device was used to complete the surgery.It was reported that in the same procedure, while using a vapr clplse90 electrode w hand cntrls device it was observed that when the electrode was connected to the aspirator, and put it into the articular cavity, it is found that there was no suction.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This is report 2 of 2 for (b)(4).

• Brand Name: VAPR COOLPULSE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25304392
• Report Number: 1221934-2026-02220
• Device Sequence Number: 9579365
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: (01)10886705010097(10)U2508002(17)280805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 228147
• Device Lot Number: U2508002
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown