MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD; SCREW, FIXATION, BONE

Catalog Number	222304
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare professional in china that during a shoulder repair procedure on (b)(6) 2023, it was observed that the 4.5 healix advance peek 3-suture anchor w/ orthocord device pulled out.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 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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.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.Investigation summary: according to the information provided, it was reported that during the surgery , the anchor was pulled out(as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.A photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the device in used condition.The anchor's distal tip is slightly damaged due to the bone surface rubbing.A manufacturing record evaluation was performed for the finished device 128l568 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 result, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an incomplete insertion or poor bone quality may happen, as per ifu 100191; bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or poor bone quality may result in anchor pullout.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.Ifu 100191.Device history lot: null device history batch: null device history review: pn:222304 lot number:128l568 there was no non conformance regarding this lot manufacturing date: 23 jan 2023.Expiry date: 31 dec 2025.Quantity:(b)(4).Release date: 10 feb 2023.

• Brand Name: 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD
• 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: 17406220
• Report Number: 1221934-2023-02819
• Device Sequence Number: 20613440
• Product Code: HWC
• UDI-Device Identifier: 10886705021406
• UDI-Public: 10886705021406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 222304
• Device Lot Number: 128L568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown