MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI 3 ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222243
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 sales rep that during an rotator cuff repair procedure on (b)(6)2021, it was observed that the 5.5 healix ti 3 w/ orthocord device broke.Another like device was used to complete the procedure.There were no adverse patient consequences 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 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.H6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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: background: it was reported by the sales rep via phone that during an unknown procedure the 5.5 healix ti 3 w/ orthocord broke.Another device was used to complete the procedure.No patient consequences or surgical delay reported.It is unknown if the device is available to be returned for evaluation.Investigation summary: the 5.5 healix ti 3 anchor w/ocord (part #: 222243, lot #: 5l29788) was received at us cq.Upon visual inspection, it was found that the device was missing the cover handle, suture, and the anchor.The suture was broken, and the distal tip was deformed and bent inwards; therefore, the complaint can be confirmed.The possible root cause for the reported condition can be that the device encountered unintended forces during its use.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.

• Brand Name: 5.5 HEALIX TI 3 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: 11753035
• Report Number: 1221934-2021-01408
• Device Sequence Number: 11644417
• Product Code: HWC
• UDI-Device Identifier: 10886705007899
• UDI-Public: 10886705007899
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 06/30/2022
• Device Model Number: 222243
• Device Catalogue Number: 222243
• Device Lot Number: 5L29788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 06/09/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/07/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1