MAUDE Adverse Event Report: DEPUY MITEK LLC US FULL RADIUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during a bankart repair procedure on (b)(6) 2021, it was observed that there were metal debris when using the 4 mm full radius blade plus device.There were fragments generated but were not all removed by suction.It was reported that there will not be a procedure to remove the rest of the fragments.There was no surgical delay nor adverse patient consequences reported.The status of the patient post-surgery was unknown.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 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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (m1911018), and no non-conformance was 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: FULL RADIUS 4.0MM 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12016312
• Report Number: 1221934-2021-01899
• Device Sequence Number: 3304355
• Product Code: HRX
• UDI-Device Identifier: 10886705022014
• UDI-Public: 10886705022014
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 283409
• Device Catalogue Number: 283409
• Device Lot Number: M1911018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 07/03/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention