MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 9X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer in (b)(6) that during a tibial fixation of the neo-ligament on (b)(6) 2021, it was observed that a part of the guidewire on the milagro advance screw 9x23mm device broke and remained inside the knee joint.According to the report, the fragment was not noticed during the surgical procedure or even at the x-ray control despite the report indicating the presence of the wire.Then on (b)(6) 2021, arthroscopic cleaning and removal of the guide wire fragment was carried out (about 5 cm).The current status of the patient was unknown.No additional information was provided.
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.
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.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l13577), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: MILAGRO ADVANCE SCREW 9X23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13225915
• Report Number: 1221934-2022-00125
• Device Sequence Number: 19822985
• Product Code: MAI
• UDI-Device Identifier: 10886705022342
• UDI-Public: 10886705022342
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143660
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 231818
• Device Catalogue Number: 231818
• Device Lot Number: 5L13577
• 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: 12/29/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Unknown