MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
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.Udi: (b)(4).Reporter is a j&j employee.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 affiliate in colombia that during an orthopedic procedure on (b)(6) 2022, it was observed that both the anchor and suture on the 5.5 healix ti anchor w/ orthocord and needles device broke upon implantation.There were no adverse patient consequences nor surgical delay 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 inthis report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, the suture appears to be broken and stripped; also, it is not attached in the device.The anchor is not assembled at the distal part of the inserter.Based on the suture condition, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l94361, and no non-conformances were identified.The photos do not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause can be associated with off axis insertion and levering during insertion.However, it cannot be conclusively affirmed.As per ifu, it is important to do not apply a bending force to the inserter, this can damage the anchor or inserter tip.Apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.Further, a review into the mitek complaints system revealed no other complaints for this lot of 300 devices that were released to distribution.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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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 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 medwach will be filed as appropriate.H10 additional narrative: investigation summary = > the product was returned to mitek for evaluation without lot information.Mitek then conducted visual inspection of device received.Upon visual inspection, the suture appears to be broken and stripped; also, it is not attached in the device.The anchor is not assembled at the distal part of the inserter and it was not returned along with the device.Based on the suture condition, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l94361, and no non-conformances were identified.The possible root cause for the reported failure can be attributed to an excessive force applied during the suture threading.However, it cannot be conclusively affirmed.As per ifu, it is important to do not apply a bending force to the inserter, this can damage the anchor or inserter tip.Apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.Further, a review into the mitek complaints system revealed no other complaints for this lot of 300 devices that were released to distribution.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: 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• 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: 15150168
• Report Number: 1221934-2022-02319
• Device Sequence Number: 5553188
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: 10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 12/31/2024
• Device Model Number: 222242
• Device Catalogue Number: 222242
• Device Lot Number: 8L94361
• 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: 07/16/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 11/28/2022; 01/19/2023
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/16/2022; 11/29/2022; 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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