MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	223131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep that postoperatively on (b)(6) 2022 to the initial case around 4 months prior, a revision rotator cuff and biceps repair was performed that determined that the rotator cuff had not healed.According to the report, that both biceps and cuff failed to heal.It was reported that the anchor was still in bone and suture was in the tendon, and the knot loop was still intact but loose and outside of the anchor body.It was reported that it was believed that the eyelit suture bar on the 5.5 healix advance br 3suture anchor w/ permacord device had broken, thus allowing the suture to be loose but knot loop still remain intact.The current 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.Udi: (b)(4).Reporter is a j&j sales representative.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.
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.Investigation summary: the complaint device is not being returned, it was implanted, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that suture was frayed and attached to the tendon; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l67433, and no nonconformances were identified.The photos do not provide enough evidence to determine root cause.Without physical evaluation of the devices reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause for the frayed suture can be attributed to procedures variables such as: snaps or other instrument to pull the suture without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it, however, this cannot be conclusively determined.As per ifu: it indicated to apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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 ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD
• Common Device Name: SOFT-TISSUE ANCHOR, 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: 15716877
• Report Number: 1221934-2022-03403
• Device Sequence Number: 20497333
• Product Code: MAI
• UDI-Device Identifier: 10886705024827
• UDI-Public: 10886705024827
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 223131
• Device Catalogue Number: 223131
• Device Lot Number: 8L67433
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/20/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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 Age: 62 YR
• Patient Sex: Female