MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX PEEK ANCH.W/OCORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 222205

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2024

Event Type  malfunction  

Event Description

It was reported from china that during a rotator cuff repair procedure, it was observed that the suture on the 4.5 healix peek anch.W/ocord device broke off when tightened.Another like device was used to complete the procedure.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.

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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.Investigation summary: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Upon visual inspection of the photo provided it was observed that the suture is completely out of the device and it is broken into two pieces.The overall complaint was confirmed as the observed condition of the 4.5 healix peek anch.W/ocord would contribute to the complained device issue.A review of the batch manufacturing records was conducted on finished lot number 237l118, and no related non-conformances were identified.Based on the investigation findings, the root cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure; an excessive tension could have been applied to the suture and consequently it broke.As per ifu: apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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 complaint condition.As part of depuy synthes mitek 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.

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.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.

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.Additional narrative: investigation summary: the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the device received.Visual inspection reveled that the device was returned with the sutures broken, the anchor was not attached no the inserter, it does not show structural anomalies as well as the rest of the device.The overall complaint was confirmed as the observed condition of the 4.5 healix peek anch.W/ocord would contribute to the complained device issue.Based on the investigation findings, the root cause can be traced to procedural variables, such handling of the device or product interaction during procedure; an excessive tension could have been applied to the suture and consequently it broke.As per ifu: apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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 complaint condition.As part of depuy synthes mitek 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.Device history review: a review of the batch manufacturing records was conducted on finished lot number 237l118; and no related non-conformances were identified.

• Brand Name: 4.5 HEALIX PEEK ANCH.W/OCORD
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19184715
• MDR Text Key: 341391831
• Report Number: 1221934-2024-01368
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705007530
• UDI-Public: 10886705007530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 222205
• Device Lot Number: 237L118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/07/2024; 05/13/2024; 05/16/2024
• Supplement Dates FDA Received: 05/09/2024; 05/15/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 60 KG