MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ O/C DS CP-2 *EA; STAPLE, FIXATION, BONE

Catalog Number	222984
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
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.A1: patient identifier: (b)(6).E1: the initial reporter's name, facility name and address were not provided.H4: the device manufacture date is currently unavailable 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
This is report 2 of 3 for (b)(4).It was reported through a post market study that a patient had undergone a rotator cuff repair procedure with biceps tenodesis and supra + subscapularis repair on (b)(6) 2024, using two 4.75 healix advance kntls br devices and one super qa+ o/c ds cp-2 device.According to the report, a post operative fall occurred resulting in anatomic neck fracture of the proximal humerus and a retear of the rotator cuff.It was reported that this had ultimately appeared to have healed but a reverse shoulder arthroplasty procedure was needed and performed on (b)(6) 2024.There was no delay in the procedure reported.The status of the patient 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 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.Device was used for treatment, not diagnosis.H4: the device manufacture date has been updated accordingly.Investigation summary: the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.Investigation summary: the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through clinical research data.The clinical research data indicated a j&j medtech orthopaedics product failure(s).Since there was no contact information, no follow-up attempts could be performed.It is unknown if complaints derived from this clinical research data were previously reported and documented in the j&j medtech orthopaedics complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.A manufacturing record evaluation was performed for the finished device lot number (194l709), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.

• Common Device Name: STAPLE, FIXATION, BONE
• 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: 20440591
• Report Number: 1221934-2024-03657
• Device Sequence Number: 18211634
• Product Code: JDR
• UDI-Device Identifier: 10886705008629
• UDI-Public: (01)10886705008629(10)194L709(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 222984
• Device Lot Number: 194L709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female