MAUDE Adverse Event Report: DEPUY MITEK LLC US BRISTOW-LATARJET 28MM SCREW,TOP-HAT(1); LIGAMENT ANCHOR

Catalog Number	285111
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)- incomplete.The lot number is currently unavailable.The complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, 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.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 etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Ow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an open laterjet surgical procedure, it was observed that the bristow-latarjet 28mm screw,top-hat(1) did not "bit" and the top hat backed out of the coracoid.According to the reporter, the event occurred when the surgeon implanted the top hat.It was further reported that the implants were removed and discarded.A small screw and washer had to be used to complete the procedure with no new hole.There was a minute delay in the surgical procedure.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: BRISTOW-LATARJET 28MM SCREW,TOP-HAT(1)
• Common Device Name: LIGAMENT ANCHOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8245040
• Report Number: 1221934-2018-51532
• Device Sequence Number: 1788681
• Product Code: HWC
• UDI-Device Identifier: 10886705020621
• UDI-Public: 10886705020621
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2016

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: 285111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2016
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1