MAUDE Adverse Event Report: DEPUY MITEK MILAGRO INTERFERENCE SCREW, 8 X 30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2014
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 received and inspected.The anchor is broken near its distal end confirming this complaint.Visual observation of the broken anchor indicates the external geometry of the screw was not damaged as the threads did not strip during insertion.It was reported the screw broke while tightening.It is a possibility the tapping was off angle or excessive force was used while tapping causing the screw to break.Other than this possibility, we cannot discern a root cause for this failure.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints from this lot released for distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.(b)(4).This report is being filed from the remetrex 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 by the affiliate in (b)(6) that during anterior cruciate ligament tibial fixation, the milagro screw head broke while tightening then the screw cracked.It was reported that a spare screw device was used to complete the procedure.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MILAGRO INTERFERENCE SCREW, 8 X 30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7738843
• Report Number: 1221934-2018-52780
• Device Sequence Number: 11042350
• Product Code: MAI
• UDI-Device Identifier: 10886705010783
• UDI-Public: 10886705010783
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2014

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 Expiration Date: 01/01/2016
• Device Catalogue Number: 231815
• Device Lot Number: 3671845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2014
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1