MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR ARCTIC ELECTRODE-CHISEL; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Two complaint devices were received and forwarded to the manufacturer for evaluation.The first device shows signs of activation at the tip and the distal section of the shaft shows signs of damage both to articulating feature.The device failed continuity tests on the active circuit and hipot.Further investigation revealed that the active wire has become severed during use.The nature of the damage to the articulating feature of the device would suggest the device has been subjected to undue force during use or continued usage past the articulation failure.The second device shows signs of activation at the tip and the distal section of the shaft shows signs of damage both to articulating feature.The device failed continuity tests on the return circuit.Further investigation revealed that the return wire has become severed during use.The nature of the damage to the articulating feature of the device would suggest the device has been subjected to undue force during use or continued usage past the articulation failure.The dhr review performed for complaint device lot number u1512011 has not indicated any issues with the manufacturing process that might explain the failures observed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this batch of devices that were released to distribution.From the investigation, the cause of the reported failure for both devices to be misuse/excessive force therefore no corrective actions could be determined to implement.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.¿ dhr review: ¿ part number: 225030; ¿ supplier lot number: u1512011; ¿ release to warehouse date: 12/22/2015; ¿ manufacturing date: 12/16/2015; ¿ expiration date: 2/28/2017; ¿ supplier: (b)(4); ¿ manufacturing site: (b)(4); ¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Udi: (b)(4).
Event or Problem Description
It was reported that during a hip procedure the mechanism that allows the articulating tip to move on two of the vapr arctic hip chisel tip electrodes is broken.Nothing broke off in the patient and that the electrodes are from the same lot number.The surgeon completed the procedure with a third device from the same lot number with no patient consequences or delays.

• Brand Name: VAPR ARCTIC ELECTRODE-CHISEL
• 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: 8286363
• Report Number: 1221934-2019-56231
• Device Sequence Number: 13488143
• Product Code: GEI
• UDI-Device Identifier: 10886705022519
• UDI-Public: 10886705022519
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: 02/28/2017
• Device Catalogue Number: 225030
• Device Lot Number: U1512011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1