MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model 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	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the vapr 3.5mm hook 1-piece electrode did not have the hook part after it was used on the patient.The surgeon decided to explore the shoulder joint since that was where it detached but unable to find it.It was reported that the surgeon decided to continue with the procedure without finding the tip.The status of the patient post-surgery was unknown.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the device was received and evaluated in juarez laboratory.Visual inspection revealed that the hook on the tip is not attached.The piece was not returned.The shaft appeared to be slightly deformed.The cable is in good condition as well as the connector and pins.The device was sent to supplier for further evaluation.The vapr 3.5mm hook 1-piece electrode -ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.Visual inspection revealed that the device has not been returned in its original packaging.The active tip (hook) of the electrode is confirmed to be missing.The shaft of the device does show to have a degree of misalignment.The active tip of the device does show a ¿sharp¿ fracture face, suggesting that no, or very minimal activation was conducted post failure.The ceramic tip at the distal end of the device does show some degree of marking.No obvious visual damage to the device shaft, handle, cable or plug.The electrical and functional test were performed; as a result, no fault found.Due to the condition of the distal tip of the device, only minimal activation conducted.A dhr review has been performed for the complaint device lot numbers u1909056; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the investigation findings and ra review no correction action has been implemented.The customer¿s device was manufactured in october 2019.It can be confirmed that the active tip of the device.Based on the condition of the device shaft we have determined the root cause of the failure to be excess mechanical force during use - misuse, therefore no further investigation is possible.From the information received there is no evidence that the detached tip remained inside the patient.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12509389
• Report Number: 1221934-2021-02765
• Device Sequence Number: 19655555
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: 10886705009718
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 227305
• Device Catalogue Number: 227305
• Device Lot Number: U1909056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 01/21/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 12/06/2021; 01/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown