MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 5X30; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device is not being returned, it was implanted, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformance were identified for this part-lot number combination per qlik query executed (b)(6) 2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.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.
Event or Problem Description
It was reported that during a mpfl procedure for knee surgery, the first 5x30mm milagro screw was being inserted and the tip of the implant broke off in the patient.The case was completed with another like-screw.Fragments were generated, but the tip of the implant remained in the patient.Patient's bone quality was reported as decent.Same bone hole was used to complete the procedure.There was a three minute delay to open the new implant and no patient consequence was reported.This is report 1 of 1 for (b)(4).

• Brand Name: MILAGRO INSCR SMALL SIZE 5X30
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8575345
• Report Number: 1221934-2019-56982
• Device Sequence Number: 381298
• Product Code: MAI
• UDI-Device Identifier: 10886705010721
• UDI-Public: (01)10886705010721
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 09/30/2020
• Device Model Number: 231804
• Device Catalogue Number: 231804
• Device Lot Number: L630312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/02/2019
• Patient Sequence Number: 1