MAUDE Adverse Event Report: DEPUY MITEK LLC US MINIQA+ # ORTHOCORD OS-2; STAPLE, FIXATION, BONE

Catalog Number	212038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date was unknown.
Event or Problem Description
It was reported by the sales rep that during an unspecified surgical procedure on (b)(6) 2024 the miniqa device asks for another anchor of 1.8, passed it and when the specialist wanted to make a knot with the first anchor that passed, the suture broke.This was dissilachada of the suture, the specialist tells not to charge that anchor because it was lifted immediately because there were no anchors of 1.3 which are the ones that surgeon always uses.The specialist experienced discomfort.The procedure was completed successfully, without affecting the patient.There were no surgery delays.Another like device was used to complete the procedure.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 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.Photos returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned photos.Upon visual inspection of the photos, it was noted that the suture is broken and frayed, also partial parts of the suture are impregnated with biological matter.The overall complaint was confirmed as the observed conditions of the miniqa+ # orthocord os-2 would contribute to the complained devices issue.¿ based on the investigation findings the potential root cause can be traced to procedural variables, such handling of the device, or product interaction during procedure; excessive tension was applied and consequently caused the suture breakage.As per ifu excessive tension may overload the anchor or suture.Therefore 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 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.
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.H4: updated.

• Brand Name: MINIQA+ # ORTHOCORD OS-2
• 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: 20433456
• Report Number: 1221934-2024-03644
• Device Sequence Number: 18049069
• Product Code: JDR
• UDI-Device Identifier: 10886705001866
• UDI-Public: (01)10886705001866(10)166L265(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 212038
• Device Lot Number: 166L265
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 10/14/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/24/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown