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

Model Number	231819
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.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.
Event or Problem Description
This report is being filed after the review of a clinical research report for clinical safety and performance of milagro advance br interference screws in knee collateral ligament repairs.Findings are as follows: patient #4 , date of surgery: (b)(6) 2017.Medial collateral ligament repair.Milagro advance br 231819 right 22 female.Date of injury: (b)(6) 2016.Reason for injury: sports.Postoperative arthrofibrosis: yes (b)(6) 2017.Complication: patient had tibial eminence fracture.Re-operation: medial collateral ligament repair (b)(6) 2017.Arthrofibrosis; acl tear; lateral meniscus tear; knee loose bodies, mua (manipulation under anesthesia), partial lateral meniscectomy, loose body removal, lysis of adhesions, acl reconstruction.
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 :according to the information provided, it was reported that the patient had a tibial eminence fracture.No patient name or contact information was provided, therefore no follow ups can be completed at this time.Since the complaint device was not returned, we cannot determine a root cause for the reported event.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 10X23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11871912
• Report Number: 1221934-2021-01633
• Device Sequence Number: 922582
• Product Code: HWC
• UDI-Device Identifier: 10886705022236
• UDI-Public: 10886705022236
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 231819
• Device Catalogue Number: 231819
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR