MAUDE Adverse Event Report: DEPUY MITEK LLC US 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231819
Medical Device Problem Codes	Break (1069); Device Contamination with Body Fluid (2317); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
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.Udi: (b)(4).Investigation summary: the device was returned and evaluated.Upon visual inspection it could be observed the anchor broken and biological residues on it.A manufacturing record evaluation was performed for the finished device lot number: 8l45018, and no nonconformances 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 broken tapered screw can be attributed to procedural variables, such handling of the device or product interaction during procedure.The possible root cause could be related to a failure to engage until fully seated position of the tapered screw during implantation and when passing the screw, it got caught in the part of the screwdriver and at the moment to remove it, the screw had to break.However, it cannot be conclusively affirmed.As per ifu- 111245, it is mandatory to completely seat the milagro br interference screw onto the correct driver for proper implant delivery.Notching and/or tapping are necessary when inserting the interference screw with bone tendon grafts.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 a healthcare professional in colombia that during an unknown surgery on (b)(6) 2022, it was observed that the 10x23mm milagro advance interference screw device got caught in the part of the screwdriver when passing; and the only way to remove it was by breaking it.During in-house engineering evaluation, it was determined that upon visual inspection it could be observed that the device was broken and had biological residues on it.Another like device was used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, 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: 15418889
• Report Number: 1221934-2022-02839
• Device Sequence Number: 6526250
• Product Code: HWC
• UDI-Device Identifier: 10886705022236
• UDI-Public: 10886705022236
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123362
• 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: Physician
• 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: 07/31/2024
• Device Model Number: 231819
• Device Catalogue Number: 231819
• Device Lot Number: 8L45018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG