MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR2.3MM WEDGESHRT 1-PCE ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email that during arthroscopy the vapr2.3mm wedgeshrt 1-pce electrode -ea has broken.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that all fragments were fully washed out and successfully removed from the patient.It was reported that there was a surgical delay of some time but no exact number of minutes mentioned.It was reported that the case was completed.It was reported that an alternative product readily available.It was reported there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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 = > according to the information provided, it was reported that during arthroscopy the vapr2.3mm wedgeshrt 1-pce electrode -ea has broken.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [u1809026] number, and no non-conformances were identified. 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.Device history lot = > a manufacturing record evaluation was performed for the finished device [u1809026] number, and no non-conformances were identified.

• Brand Name: VAPR2.3MM WEDGESHRT 1-PCE ELECTRODE -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9814297
• Report Number: 1221934-2020-00816
• Device Sequence Number: 19563540
• Product Code: GEI
• UDI-Device Identifier: 10886705009640
• UDI-Public: 10886705009640
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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 Expiration Date: 08/31/2021
• Device Model Number: 227213
• Device Catalogue Number: 227213
• Device Lot Number: U1809026
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/20/2020; 05/24/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/23/2020; 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1