MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO SMALL SIZE INTERFERENCE SCREW, 6 X 30 MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2014
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 is a possibility the tapping was off angle or excessive force was used while tapping or inserting the screw causing the screw to break.No information was available regarding the instruments used during the procedure.We cannot discern a root cause for this failure mode.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 similar complaints from this lot of devices.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
It was reported that the screws in question were used for outside-in acl reconstruction using btb graft.During insertion of milagro br 6 x 30 mm into the femoral side, it could not be inserted further in the middle of the bone hole.When the surgeon reversed and tried pulled it out, the tip of the screw (3-5 mm) was broken and the broken piece got stuck between the bone hole and the graft.The surgeon removed the broken piece using an osteotome and raspatory, and fixed the graft with the competitor¿s screw (6 x 30 mm) instead.For the tibial side, milagro advance 8 x 23 mm was used, however, the desired tension was not obtained by the screw.The surgeon removed the screw and re-fixed with the competitor¿s dsp.The procedure was completed without any surgical delay or harm to the patient because of these problems.The backup device was used to complete the case.Please see also medwatch report 1221934-2018-52390.

• Brand Name: MILAGRO SMALL SIZE INTERFERENCE SCREW, 6 X 30 MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7720195
• Report Number: 1221934-2018-52387
• Device Sequence Number: 904546
• Product Code: MAI
• UDI-Device Identifier: 10886705010769
• UDI-Public: 10886705010769
• 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): 08/05/2014

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: 04/30/2015
• Device Catalogue Number: 231809
• Device Lot Number: 3611678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2014
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1