MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 7X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231831
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Depuy synthes mitek received and evaluated the complaint device.Visual inspection revealed the device was broken in five pieces.The screw was broken towards its distal end along the screw thread.The four small pieces of the distal end of the screw were deformed and showed evidence of thread damage from insertion.The pattern of the screw break along the thread line indicates potential use of excess torsion during insertion.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality, or using incorrect instrumentation for preparing the bone hole; however, the root cause of this specific device failure cannot be conclusively determined.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.No nonconformances were identified for this part-lot number combination per qlik query executed 11/14/2018.Review conducted per (b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Udi: (b)(4).
Event or Problem Description
It was reported that screw has been broken during beginning of the procedure.No consequences for the patient reported.The physician used another one product the same type.

• Brand Name: MILAGRO ADVANCE SCREW 7X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8288917
• Report Number: 1221934-2019-56258
• Device Sequence Number: 2575771
• Product Code: HWC
• UDI-Device Identifier: 10886705023301
• UDI-Public: 10886705023301
• Combination Product (Y/N): N
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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: 04/30/2019
• Device Catalogue Number: 231831
• Device Lot Number: 3903985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1