MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.0 MM BARREL BURR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283869
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare professional in brazil that during an orthopedic procedure on (b)(6) 2023, it was observed that the 5.0 mm barrel burr plus device broke.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: investigation summary - the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual inspection revealed that the inner/outer were broken near the proximal part.Upon magnification, mechanical deformation and wear marks near the broken part were found.The complaint reported was confirmed.There were no details provided as to when this failure has occurred; therefore, a definite root cause for this failure cannot be determined.The possible root cause could be related to procedural variables, such handling of the device or product interaction during procedure.It is unknown at what point in time this failure occurred.A manufacturing evaluation was performed; as a result, if the damage occurred once the sample was getting out from the bag, the issue could be related to the handle during the procedure.A manufacturing record evaluation was performed for the finished device lot number:m2206017, and no nonconformances were identified.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.
Additional 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Investigation summary: the complaint device has not been returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the blade was broken near the proximal part.The complaint reported was confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.There were no details provided as to when this failure has occurred; therefore, a definite root cause for this failure cannot be determined.The possible root cause could be related to procedural variables, such handling of the device or product interaction during procedure.It is unknown at what point in time this failure occurred.A manufacturing evaluation was performed; as a result, if the damage occurred once the sample was getting out from the bag, the issue could be related to the handle during the procedure.A manufacturing record evaluation was performed for the finished device lot number:m2206017, and no nonconformances were identified.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: 5.0 MM BARREL BURR PLUS
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• 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: 17072942
• Report Number: 1221934-2023-02296
• Device Sequence Number: 20359716
• Product Code: HRX
• UDI-Device Identifier: 10886705023080
• UDI-Public: 10886705023080
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041824
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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 Model Number: 283869
• Device Catalogue Number: 283869
• Device Lot Number: M2206017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 08/01/2023; 08/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/02/2023; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• Patient Sex: Male