MAUDE Adverse Event Report: DEPUY MITEK LLC US 6X12 MILAGRO INTERFRENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Udi: (b)(4) - incomplete.Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
It was reported that upon insertion of milagro 6x12 interference screw, the screw broke.Doctor used an additional milagro 6x12 interference screw and it stayed intact.There were no patient consequences.
Additional 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
It was reported that upon insertion of milagro 6x12 interference screw, the screw broke.Doctor used an additional milagro 6x12 interference screw and it stayed intact.There were no patient consequences.Additional information was received on august 9th, 2018.It was reported that the event did not result in a delay greater than 30 minutes or the inability to complete the surgical procedure.The reporter stated that fragments were retrieved using a grasper.It was reported that a spare device was available for use.The reporter stated that the surgeon used a driver that was not intended for use with the milagro, per the surgeons preference.There was no surgical intervention and no portion of the device remained in the patient.
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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Additional information: patient identifier: the patient identified was inadvertently missed in the initial report and has been updated as e1402739991.Subsequent follow-up with the customer, additional information was received.It was clarified that there were two 6x12 milagro interfrence screw devices involved but only one broke while the other one stayed intact.

• Brand Name: 6X12 MILAGRO INTERFRENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7724312
• Report Number: 1221934-2018-54217
• Device Sequence Number: 757019
• Product Code: MAI
• UDI-Device Identifier: 10886705021956
• UDI-Public: 10886705021956
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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 Catalogue Number: 231813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 11/09/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/28/2018; 11/09/2018
• Patient Sequence Number: 1