MAUDE Adverse Event Report: DEPUY MITEK MILAGRO ADVANCE SCREW 8X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number 231817

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.(b)(4) - incomplete.The expiration date is not currently available.(b)(6).

Event Description

It was reported that it was impossible to implant the screw.Screw was twisted.Not used on patient.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate evaluation statement: the complaint device was received and evaluated.Visual observations revealed the threaded portion of the screw is deformed.This complaint can be confirmed.This type of failure is consistent with device being handled improperly or excess force being exerted while use on the device.Other than this possibility, a root cause is undetermined for this reported failure.A device history record (dhr) review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.Udi: (b)(4).

Event Description

Additional information received from affiliate on 09january 2018: reportedly the issue was detected pre-operatively so there was no surgical delay.The procedure was completed successfully with no impact to the patient.

• Brand Name: MILAGRO ADVANCE SCREW 8X23MM
• Type of Device: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA
• MDR Report Key: 7170735
• MDR Text Key: 96594542
• Report Number: 1221934-2018-50025
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K143660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 231817
• Device Lot Number: L436626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Date Manufacturer Received: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1