MAUDE Adverse Event Report: DEPUY MITEK LLC US ABSOLUTE G-W NTNL 1.1MMX15 6PK; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	254514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
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 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.Device was used for treatment, not diagnosis.H11 additional narrative: d4, h4, udi: the serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.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
It was reported that during a hamstring anterior cruciate ligament procedure, it was discovered that the pin tip of the nitinol guidewire 1.1mm x 38.1cm (15 inches) device broke off in the graft within the patient's tibia.It was further reported that the device broke at the 30 mm line, breaking the 10×30 screw.The procedure was successfully completed.An x-ray was used to determine pin placement, and the graft had to be cut out and redone with a new button and screw.There was twenty-minute delay to the surgical procedure.There was patient involvement reported.No injuries were reported, but there was medical intervention required.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Device was used for treatment, not diagnosis.H11 additional narrative: d4, udi: lot number: the device lot number and expiration date were unknown the initial medwatch report.The lot number and expiration date has been identified and the udi has been updated accordingly.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Device was used for treatment, not diagnosis.H11 additional narrative: b5, d10: upon further review of this complaint, it was determined that the milagro advance screw 10x30mm device was also involved in this event.Therefore, the device has been included as a concomitant medical products section.Furthermore, the event numbering represented in the initial report has been updated to ¿report 1 of 2 for the same event¿ d10: concomitant med products and therapy dates: milagro advance screw 10x30mm device, 8/19/2024.
Event or Problem Description
This is report 1 of 2 for (b)(4).It was reported that during a hamstring anterior cruciate ligament procedure, it was discovered that the pin tip of the nitinol guidewire 1.1mm x 38.1cm (15 inches) device broke off in the graft within the patient's tibia.It was further reported that the device broke at the 30 mm line, breaking the 10×30 screw.The procedure was successfully completed.An x-ray was used to determine pin placement, and the graft had to be cut out and redone with a new button and screw.There was twenty-minute delay to the surgical procedure.There was patient involvement reported.No injuries were reported, but there was medical intervention required.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Device was used for treatment, not diagnosis.H11: additional narrative: investigation summary - the product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.Visual inspection revealed that the device is broken into two pieces.Also, it is slightly impregnated of biological matter.The overall complaint was confirmed as the observed condition of the absolute g-w ntnl 1.1mmx15 6pk would contribute to the complained device issue.Based on the investigation findings, the potential root cause is traced to procedural variables, such handling of the device or product interaction during procedure; the guidewire may have become entrapped, and the excessive force applied at the moment of manipulating caused the guidewire to break.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.

• Brand Name: ABSOLUTE G-W NTNL 1.1MMX15 6PK
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 20076845
• Report Number: 1221934-2024-02974
• Device Sequence Number: 6405088
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: (01)10886705013050(10)214L008(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2024

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: 07/31/2026
• Device Catalogue Number: 254514
• Device Lot Number: 214L008
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 09/16/2024; 09/26/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/12/2024; 09/16/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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