MAUDE Adverse Event Report: DEPUY MITEK LLC US S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227355
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information received, it was reported that during the rotator cuff repair operation, after connecting with generator, does not function at all, the screen did not show any alert code.No additional information could be provided.The complaint device was received and evaluated in (b)(6) laboratory.Visual inspections revealed saline and blood residues into the suction tube.No visual damaged found in the shaft and cord.The electrode was tested, an "output shorted "error appeared during ablate and coagulate mode.Therefore, the device was sent to manufacturer for further evaluation.The s50 sm.Dia.Electrode w/integ.Hndpiece-ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection revealed the device has not been returned in its original packaging.No clear evidence of activation at tip.Procedural residue visible in suction tube.Finally, no visible damage to the device shaft, handle, cable or plug.The electrical test was passed.The functional test was performed, as a result, the coagulation and ablation mode were failed, an output shorted message was appeared.The change in performance could be induced by either positioning the tip close/touching the beaker sides or placing the tip in the center of the saline filled beaker.The different positions would vary the amount of energy being applied to the tip by the generator.The investigation also found the capacitance value was also above top tolerance, however, this did not affect the settings.A dhr review has been performed for lot u2001074; 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 product no initial containment action related to the individual complaint is recommended.From our investigation we were able to confirm a fault with the device.The failure observed during the investigation is likely to have been caused by an incomplete adhesive seal resulting in an intermittent output shortage error being displayed.Process controls are already in place to maximize the likelihood of detection of this failure mode, and a review of the product manufacturing plans has shown no changes to the manufacturing process have been introduced in the last 12 months which would increase the occurrence of failure.At this point in time, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: a dhr review has been performed for lot u2001074; 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 product no initial containment action related to the individual complaint is recommended.
Event or Problem Description
It was by the affiliate in (b)(6) that during a rotator cuff repair procedure and after connecting to the generator, the 50 sm.Dia.Electrode w/integ.Hndpiece-ea device did not function at all and the screen did not show any alert code.During in-house engineering evaluation, it was determined that the coagulation and ablation mode had failed.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13053808
• Report Number: 1221934-2021-03830
• Device Sequence Number: 11164985
• Product Code: GEI
• UDI-Device Identifier: 10886705009732
• UDI-Public: 10886705009732
• Combination Product (Y/N): N
• PMA/510(K) Number: K120095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 12/31/2022
• Device Model Number: 227355
• Device Catalogue Number: 227355
• Device Lot Number: U2001074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown