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

Catalog Number	231804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed 05/22/2019.Multiple attempts for additional information were made with no response.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.Patient identifier: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via cst that during a mpfl repair procedure the first 5 x 30 mm milagro screw was being inserted into the patient's bone tunnel when the distal tip of the screw broke off.The breakage occurred after the successful purchase of the lupines and passing of the graft through the bone tunnel.A 5 x 23 mm milagro screw was opened and experienced the same problem.The broken tips of the implants remained in the patient as the implants are made from br material.There was a five minute surgical delay to open the new milagro screw.It is unknown if the case was completed successfully.

• 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: 8647808
• Report Number: 1221934-2019-57199
• Device Sequence Number: 14006229
• Product Code: MAI
• UDI-Device Identifier: 10886705010721
• UDI-Public: 10886705010721
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 231804
• Device Lot Number: L936858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/28/2019
• Patient Sequence Number: 1