MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 6X23; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number 231807

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Not Applicable (3189)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This is report 2 of 2 for the same event.It was reported by the affiliate in (b)(6) that during an acl (anterior.Cruciate ligament) repair surgery, it was observed that a milagro inscr small size 6x23 broke in the femoral tunnel during insertion while fixing a btb-transplant.A second 6 mm screw broke as well.In the end, a 7mm milagro advance screw was used.There was a delay of 20 minutes to complete the surgery successfully.There were fragments generated and remained in the femoral tunnel but they are going to be resorbed.There were no patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary according to the information provided, it was reported that two milagros 6 mm screws were broken in the femoral tunnel during insertion while fixing a btb-transplant.The complaint device was received and evaluated.Visual observations confirm that both screws are completely broken and were received in the same plastic bag.The complaint can be confirmed.The possible root cause for the reported failure can be associated that for btbs transplants, especially in hard bone, notching and tapping is required.The two screws breakages did not perform the first step of notching to clear room for the screw to advance into the tunnel.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [6l41238] number, and no non-conformances were identified.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.

• Brand Name: MILAGRO INSCR SMALL SIZE 6X23
• Type of Device: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10276547
• MDR Text Key: 200434398
• Report Number: 1221934-2020-01840
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010752
• UDI-Public: 10886705010752
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 231807
• Device Catalogue Number: 231807
• Device Lot Number: 6L41238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/13/2020
• Supplement Dates FDA Received: 07/23/2020; 08/14/2020
• Patient Sequence Number: 1