MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 9X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231822
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported by affiliate via email, that during an acl procedure, when the surgeon was going to insert a 9x30mm milagro advance interference screw in the tibia, the implant suffered a rupture by the tip.No surgical delay or patient consequence reported.No sample was kept.
Additional Manufacturer Narrative
Depuy dsayvnitdh epsr iimsm esrumbamnitting 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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during an acl procedure, when the surgeon was going to insert a 9x30mm milagro advance interference screw in the tibia, the implant suffered a rupture by the tip.The complaint device was received and evaluated.Visual observations revealed that the distal portion of the milagro was broken.It was determined that this type of failure was consistent with device being dropped or hitting other metal instruments or excess force being exerted while use on the device.Other than this possibility, a root cause was undetermined for this reported failure.A manufacturing record evaluation was performed for the finished device [4l02041] 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.Device history lot: a manufacturing record evaluation was performed for the finished device [4l02041] number, and no non-conformances were identified.
Additional Manufacturer Narrative
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.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there were no factors that caused the device breakage.It was reported that the surgery was completed successfully by using another device.It was reported that an alternative product was readily available.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).It was reported that all fragments were easily retrieved from the patient with no consequences.

• Brand Name: MILAGRO ADVANCE SCREW 9X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9617535
• Report Number: 1221934-2020-00265
• Device Sequence Number: 10909169
• Product Code: HWC
• UDI-Device Identifier: 10886705022274
• UDI-Public: 10886705022274
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 231822
• Device Catalogue Number: 231822
• Device Lot Number: 4L02041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 03/03/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/11/2020; 04/24/2020
• Patient Sequence Number: 1