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

Catalog Number	231800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
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.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via cst that during a lca reconstruction at the moment of introducing the screw to fix the ligament it was observed that the screw had fractured.No sharp force was exerted.In trying to confirm if the great majority of the screw had been already inside the tunnel we thought that the ligament had already been fixed, however we detected that they were pure residues of the screw, practically like a flour, for this reason another screw was used, the expiration date of the screw was observed and the box was "ok".The implant before use was completely sealed.What is left of the screw is saved for its respective study.
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.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, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No lot number was provided which precludes in conducting a manufacturer record evaluation.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).

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8855674
• Report Number: 1221934-2019-57880
• Device Sequence Number: 2541159
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2019

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: 231800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/02/2019
• Patient Sequence Number: 1