MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM SIDE 21 DEG -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225302
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the affiliate in (b)(6) that postoperatively to an arthroscopic rotator cuff repair surgery on (b)(6) 2022 using a vapr 3.5mm side 21 deg device, the patient was x-rayed when it was located a metal-like substance (approximately 2 to 3 mm large) inside the deltoid.According to the report, it was confirmed that a part of the electrode¿s coil had chipped.It was further reported that the surgeon concluded that the chipped fragment in the lesion was likely to come from the electrode in question.The status of the patient was unknown.No additional information was provided.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 SIDE 21 DEG -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14337350
• Report Number: 1221934-2022-01351
• Device Sequence Number: 14780574
• Product Code: GEI
• UDI-Device Identifier: 10886705009268
• UDI-Public: 10886705009268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974022
• 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

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 Model Number: 225302
• Device Catalogue Number: 225302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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