MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - CUTTING INSTRUMENT; CUTTER, SURGICAL

Catalog Number UNK - CUTTING INSTRUMENT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: e3: reporter is a j&j sales representative.D1, d2, d3, d4, g4, h4, udi, g1-1: this report is for an unknown cutting instrument.The product code is unknown.Therefore, the brand name, catalog number, lot number, 510k classification, expiration date and the manufacture date are unknown, therefore the udi cannot be completed.Udi: (01)unknown as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep that during an unknown procedure on an unknown date, it was observed that an unknown shaver blade device left metal shavings inside the patient.They were little metal fragments which were not removed from the patient.There was no additional surgery required.The reporter stated that they were unsure how the patient was doing.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the cutter inside the tissue and it appeared to have some metal shavings.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.Based on photo received, this complaint can be confirmed.The possible root cause for reported failure can be attributed to blade wear and degradation.Excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device.Besides, a hand piece used in this procedure where the blade is assembled was not received for evaluation, potential ways to reduce shedding is to ensure all hand pieces are properly serviced and maintained.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: UNK - CUTTING INSTRUMENT
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18084954
• MDR Text Key: 327540698
• Report Number: 1221934-2023-04035
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CUTTING INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1