MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIXADV BR3SUTANC PCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	223131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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 (b)(6) that during an unknown procedure on (b)(6) 2021, it was observed that the tip of the anchor device broke off during suturing.Another like device was used in the same bone hole to complete the procedure with a delay of about 30 minutes.All broken pieces were removed.There were no adverse patient consequences reported.The device was brand new and its first use when the issue occurred.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 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.Investigation summary: according to the information provided, it was reported that the tip of the anchor broke off during suturing.The complaint device was received and evaluated.Upon visual inspection, it was observed that the inserter shaft and distal tip are in good condition, no structural anomalies were found.The handle cover was removed to verify the sutures; however, the sutures were not returned.When reviewing the anchor, it was found that the anchor is damaged at the top, where the anchor connects with the inserter, also the little bar that holds the suture is broken.A manufacturing record evaluation was performed for the finished device 7l00422 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection performed, this complaint can be confirmed.The root cause for the reported issue can be attributed to the handling of the device, an excessive force was applied to the sutures at the moment of tightening leading to a damaged and broken anchor.As per ifu 111791: 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 monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: 5.5 HEALIXADV BR3SUTANC PCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11651386
• Report Number: 1221934-2021-01176
• Device Sequence Number: 3658454
• Product Code: MAI
• UDI-Device Identifier: 10886705024827
• UDI-Public: 10886705024827
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 05/31/2023
• Device Model Number: 223131
• Device Catalogue Number: 223131
• Device Lot Number: 7L00422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1