MAUDE Adverse Event Report: DEPUY MITEK LLC US FULL RADIUS 4.0MM 5PK; ARTHROSCOPE

Catalog Number	283409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
Report 1 of 3 for (b)(4).It was reported that during an arthroscopy surgical procedure, while using 3x full radius 4.0mm 5pk devices, it was observed that metal abrasion occurred.It was reported that the procedure was successfully completed.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is being used into the patiens body.Few spots of metal debris can be observed.The overall complaint was confirmed as the observed condition of the full radius 4.0mm 5pk would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; excessive side loading was applied; as per ifu; excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition.The shaft has no structural anomalies.The inner and outer sleeves were separated and inspected for any visual defects that may contribute to the complaint condition.The inner blade shows friction marks on its surface near the distal end.The overall complaint was confirmed as the observed condition of the full radius 4.0mm 5pk would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; excessive side loading was applied; as per ifu; excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.

• Brand Name: FULL RADIUS 4.0MM 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA ; 9083863534
• MDR Report Key: 23814297
• Report Number: 1221934-2025-04788
• Device Sequence Number: 18479206
• Product Code: HRX
• UDI-Device Identifier: 10886705022014
• UDI-Public: (01)10886705022014(10)M2507007(17)300630
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 283409
• Device Lot Number: M2507007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 01/12/2026; 01/14/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/14/2026; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: Unknown