MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 8X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2014
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.The complaint device was released and evaluated.Visual inspection confirms the proximal end of the screw is broken.It is unknown if the insertion was off axis, if the procedure was a btb or st.In case of a btb procedure and especially in hard bone, notching and tapping is required before inserting the screw.It was reported that the channel was 7mm and a 8x30mm screw was used.No further technique details were provided that could help determine a root cause.Furthermore, no lot numbers were supplied for the applier or the needles which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.However, 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.This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that during an acl reconstruction procedure, a milagro advance screw (8x30 mm) has been crumbled into pieces.The channel was 7 mm.The screw broke on the last part of insertion when it was ninety percentage (90%) into the bone tunnel.All broken fragments were removed from the patient.The procedure was completed with another smaller milagro advance screw (8x23 mm).Patient outcome is unknown.

• Brand Name: MILAGRO ADVANCE SCREW 8X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7811028
• Report Number: 1221934-2018-51857
• Device Sequence Number: 13968506
• Product Code: HWC
• UDI-Device Identifier: 10886705022267
• UDI-Public: 10886705022267
• Combination Product (Y/N): N
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2014

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 Catalogue Number: 231821
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2014
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1