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

Catalog Number	225304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4)-incomplete.The expiration date is not currently available.
Event or Problem Description
On (b)(6) 2018, the reported device was used for the synovial resection during screw removal surgery after hto.After the surgery, the surgeon recognized that the probe tip was broken and remained in the patient¿s body.Then, the broken fragment was removed from the patient¿s body when the surgeon performed additional removal surgery later.It was brand new and the first use when the issue occurred.No further information was provided by the hospital.
Additional Manufacturer Narrative
Date received by manufacturer of follow-up 1 should be november 12, 2018.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.
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.Investigation summary: the complaint device was received and inspected.It was observed that the tip of the electrode had been separated into two separate pieces from the body of the device.This complaint can be confirmed.There is no specific root cause that could be determined at this time, however a possible root cause could be that the electrode was pressed against the bone which caused the tip to break.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.One unrelated ncr was found that would not have contributed to the reported failure.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.Udi: (b)(4).

• Brand Name: VAPR 3.5MM END 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
• MDR Report Key: 7890772
• Report Number: 1221934-2018-54648
• Device Sequence Number: 2507971
• Product Code: GEI
• UDI-Device Identifier: 10886705009282
• UDI-Public: 10886705009282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2018

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 Catalogue Number: 225304
• Device Lot Number: U1804071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 10/21/2019
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/14/2018; 10/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention