MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+#0 OC OS-2; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	212849
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed after a review of clinical dataset received from equipe zorgbedrijven nederland b.V.On clinical outcomes and complications after reinsertion of the triangular fibrocartilagous complex (tfcc) using the mitek® minilok quickanchor plus anchor with orthocord suture.Complications: three cases of recurrent distal radioulnar joint instability (3%) were scored as possibly related to the bone anchor which required additional surgical intervention.
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.D4, h4: the lot number was unknown; therefore, the expiration date and device manufacture date were unknown; and udi is incomplete.
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.H11 additional narrative: 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.Given that no lot/serial number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot/serial number becomes available, the mre review will be performed.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.

• Brand Name: MINILOK QA+#0 OC OS-2
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20894198
• Report Number: 1221934-2024-04397
• Device Sequence Number: 15686897
• Product Code: MAI
• UDI-Device Identifier: 10886705002382
• UDI-Public: (01)10886705002382(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Catalogue Number: 212849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown