MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTERFERENCE SCREW, 7 X 23MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	231800
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2015
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 proximal 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, we cannot discern a root cause for this failure with the information provided.A batch record review has been conducted for this lot of devices that were manufactured in 2014 with an expiration date of 05-2017 and the results indicate that this batch of product was processed without incident related to the failure in this complaint and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no similar complaints for this lot.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.
Event or Problem Description
It was reported by the affiliate that screw broke during drill in the fumoral bone in spite of using coracoid step tap and modular driver 23mm.Rest of the screw is in the bone.Procedure was completed with same like product.

• Brand Name: MILAGRO INTERFERENCE SCREW, 7 X 23MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7740193
• Report Number: 1221934-2018-53131
• Device Sequence Number: 1050524
• Product Code: HWC
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K032167
• 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): 02/10/2015

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: 05/31/2017
• Device Catalogue Number: 231800
• Device Lot Number: 3781291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2015
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1