MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX TI ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222253
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.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 4.5 healix ti anchor w/ocord anchor device broke.The procedure was competed with an unspecified delay.There were no adverse patient consequences 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 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.H10 additional narrative: investigation summary : according to the information provided, it was reported that the anchor broke during the procedure.The complaint device was received and evaluated.Upon visual inspection, it could be observed that the tip of the inserter is detached, on magnification, the inserter tip was found to have nick marks on its base due to continuous tapping.The anchor was not returned.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, and considering that the broken anchor was not returned, this complaint cannot be confirmed.A root cause for the detached inserter tip can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment or bending force was applied to the tip of the device.As per ifu-109139: to insert the healix ti anchor apply slight downward force on the anchor while rotating the handle in a clockwise direction and maintaining the same axial alignment throughout insertion until the etched depth marking on the handle shaft is flush with the bone.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5 HEALIX TI ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12128067
• Report Number: 1221934-2021-02104
• Device Sequence Number: 4341945
• Product Code: HWC
• UDI-Device Identifier: 10886705007998
• UDI-Public: 10886705007998
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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 Model Number: 222253
• Device Catalogue Number: 222253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 09/15/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/15/2021; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1