MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 7X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number 231816

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not being returned, it was discarded by the customer therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices with this product code that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.This report is being filed from the (b)(4) as required under mitek's cor.

Event Description

It was reported by the sales rep that the customer's 7x23 milagro taper screw cold welded to the driver and cracked during a bicep tendonesis procedure.The case was completed with another like device.There were no adverse patient consequences with a five-minute delay.The sales rep stated the device was discarded by the facility.The sales rep stated that the screw did not crack, when the driver was being removed the screw came out still on the driver after insertion.The sales rep stated that the screw was stuck on the driver therefore not allowing to stay in the bone hole.The original bone hole size was used to complete the procedure with a larger screw.The patient's bone quality was average.An assembly, 2.8mmx23mmx7.5 modular driver was used with the screw, a lot number could not be provided for the driver.The sales rep stated that the driver was discarded with the screw.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 ADVANCE SCREW 7X23MM
• Type of Device: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8281046
• MDR Text Key: 134193452
• Report Number: 1221934-2018-53953
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705022243
• UDI-Public: 10886705022243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 231816
• Device Lot Number: L205055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1