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

Model Number	223131
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 arthroscopic rotator cuff repair procedure on 1/18/2021, it was observed that the suture used on the 5.5 healixadv br3sutanc pcord device came off while the surgeon was pulling on it during suturing.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.The devices was brand new and its first use when the issue occurred.
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.H11 additional narrative: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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 two sutures of the anchor in question were applied without any issue.However, the last one among three sutures came off the anchor during suturing.This last suture came off when the surgeon pulled it during the suturing.When the last one came off, the other two sutures came off, too.The complaint device was received and evaluated.The inserter has no structural damages and is not bent.The distal tip is in good shape.The anchor was returned, upon review, it could be observed that the anchor was used and removed from the bone, rests of biological matter was found on it.A little piece of the blue suture was returned, it was found that it is broken and frayed on both ends.A manufacturing record evaluation was performed for the finished device 7l02812 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 possible root cause for the reported failure can be attributed to an excessive force applied during the suture threading, 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: 11259143
• Report Number: 1221934-2021-00309
• Device Sequence Number: 14472612
• 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,Followup
• Report Date (Section B): 01/18/2021

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: 7L02812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 03/09/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/08/2021; 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1