MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222305
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Upon visual inspection, the handle cap is missing, and it could be detected the slotted driver out of place from the handle driver.Finally, the slotted controller was easily removed from its place.A manufacturing record evaluation was performed for the finished device lot number: 9l11189, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection results, this complaint can be confirmed.The possible root cause for the condition of the device could be related to heavily use and procedural variables, such handling of the device or product interaction during procedure.However, it cannot be conclusively affirmed.As per ifu, inspect all instruments for damage before use.Do not attempt to repair.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.
Event or Problem Description
It was reported by the affiliate in germany that during a shoulder repair procedure on an unknown date, it was observed that the handle came loose when the anchor on the 5.5 healix advance peek anchor with orthocord device was being screwed.During in-house engineering evaluation, it was determined that the handle cap was missing; and it could be detected that the slotted driver was out of place from the handle driver.Finally, the slotted controller was easily removed from its place.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15293533
• Report Number: 1221934-2022-02548
• Device Sequence Number: 6181602
• Product Code: HWC
• UDI-Device Identifier: 10886705021413
• UDI-Public: 10886705021413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: 02/28/2025
• Device Model Number: 222305
• Device Catalogue Number: 222305
• Device Lot Number: 9L11189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown