MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; SCREW, FIXATION, BONE

Catalog Number	222242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from colombia that during an unspecified surgical procedure, it was observed that the suture on the 5.5 healix ti anchr w/oc +ndls device burst easily upon knotting.There was patient involvement.There were no adverse consequences to the patient 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 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: investigation summary : the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the product box was shown.Also there was a little piece of suture broken and frayed and a larger piece of broken suture with its needle.The inserter and anchor were not shown in the photo.A review of the batch manufacturing records was conducted on finished lot number 162l136: and no related non-conformances were identified.The overall complaint was confirmed as the observed condition of the 5.5 healix ti anchr w/oc +ndls would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; an excessive force was applied during tightening; 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 reported complaint condition.As part of depuy synthes 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: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20138088
• Report Number: 1221934-2024-03061
• Device Sequence Number: 19620933
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: (01)10886705007882(10)162L136(17)260331
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03/31/2026
• Device Catalogue Number: 222242
• Device Lot Number: 162L136
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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