MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTERFERENCE SCREW, 7 X 23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that the procedure was performed without tapping.Based on this information, the root cause of the break is misuse, as tapping is a required procedural step.A batch review was conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.Our results indicate that this batch 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 one dissimilar complaint for this lot of (b)(4) devices that were released to 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.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.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
The thread of the screw was broken during the surgery when the surgeon inserted the device without tapping.Titanium screw from competitor was used to complete the case.

• Brand Name: MILAGRO INTERFERENCE SCREW, 7 X 23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7799660
• Report Number: 1221934-2018-51909
• Device Sequence Number: 16659305
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2014

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: 09/30/2016
• Device Catalogue Number: 231800
• Device Lot Number: 3728433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2014
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1