MAUDE Adverse Event Report: DEPUY MITEK LLC US BRISTOW-LATARJET 32MM SCREW,TOP-HAT(1); LIGAMENT ANCHOR

Catalog Number	285121
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The lot number is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) via email that the bristow latarjet 32mm screw had a failure during the latarjet surgical procedure.The affiliate stated that the doctor followed the surgical technique indicated for the product.It was reported that at the time of screwing correctly in positioning the coracoid, the screw didn't compress but was rolled.It was mentioned that the screw must be replaced by another one.There was an hour delay in the surgery.There was patient consequence of putting a new screw (that was same diameter measure as the one that failed) the coracoid graft detached, as it could be seen next day on x-rays.It was reported that a revision surgery was needed two days after the event.There was patient involvement reported.It was not reported if there was prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.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 contaminated with organic material remains and fluid, 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).The lot number is unknown.

• Brand Name: BRISTOW-LATARJET 32MM 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: 8592268
• Report Number: 1221934-2019-57095
• Device Sequence Number: 2074973
• Product Code: HWC
• UDI-Device Identifier: 10886705020669
• UDI-Public: 10886705020669
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 285121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1