MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227305
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2026
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: the product has not returned to deput synthes, however photos were provided for evaluation.¿ visual inspection of the returned photos found the active tip detached from the electrode, the arthroscopic image showed the hook fragment inside of the tissue.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the vapr 3.5mm hook 1-piece electrode -ea would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu, carefully insert and withdraw electrodes to avoid possible damage to the device and/or injury to the patient or surgical personnel.Excessive force may damage the electrode tip assembly.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.
Event or Problem Description
It was reported that during an arthroscopic release of contracture of the patient's right frozen shoulder surgical procedure, it was observed that the hook component of the electrode 'fell off.' according the report, the hook did not come off when it was being actively used, but instead just as the user completed the procedure and was beginning to withdraw the electrode from the shoulder.The hook fell off and was seen to be lying on the upper surface of the long head of biceps.However, it then fell into the depths of the shoulder before the user could retrieve it.As this occurred at the conclusion of the arthroscopic release, the hook fell into the axillary recess of the shoulder that had already been released such that the retained hook would have become extracapsular (i.E.Outside of the shoulder compartment).It was therefore unretrievable as was demonstrated by an xray taken following the procedure.Consequences of malfunction: the patient will require regular mri scans for confirmation that its retention does not exclude the use of an mri scan in the future.
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
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: b5: during further follow up with the reporter, it was stated that the surgeon has confirmed there was no harm to the patient.

• Brand Name: VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA
• 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: 24268815
• Report Number: 1221934-2026-00557
• Device Sequence Number: 13443418
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082643
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 227305
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/12/2026; 03/09/2026; 04/23/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/09/2026; 02/19/2026; 03/10/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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