MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK 3SUT W/OC; SCREW, FIXATION, BONE

Catalog Number	222307
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	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep that during an unspecified surgical procedure on (b)(6) 2023 the 5.5 healix advance peek 3 suture anchor w/ orthocord device failed.The surgeon had to remove the anchor from placement when the sutures pulled out as he was tying his knots slight surgical delay for troubleshooting with no patient consequences reported.Device was discarded.Another like device was used to complete the procedure.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.E3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation.Therefore, the reported condition cannot be confirmed and/or duplicated.
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.Device was used for treatment, not diagnosis.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Upon visual inspection of the photo, the anchor was not in the shaft.A manufacturing record evaluation was performed, for the finished device lot number.And no non conformances were identified.According with the visual inspection of the photo, this complaint can be confirmed.The photo does not contain enough evidence to determine, why the customer experienced the failure.The possible root cause could be related to procedural variables, such handling of the device or product interaction, during procedure.However, it cannot be conclusively affirmed.As per, the instructions for use, insert the distal tip of the peek or br anchor into the bone hole, while maintaining the same axial alignment.Open the slide cover on the inserter handle and remove suture card.Remove inserter from anchor by pulling straight back on handle.Apply tension (normal force) on suture lengths, excessive force may overload the anchor or suture.Use the suture provided for soft tissue fixation.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 HEALIX ADVANCE PEEK 3SUT W/OC
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18138604
• Report Number: 1221934-2023-04139
• Device Sequence Number: 12774009
• Product Code: HWC
• UDI-Device Identifier: 10886705021420
• UDI-Public: 10886705021420
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 03/31/2026
• Device Catalogue Number: 222307
• Device Lot Number: 135L387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown