MAUDE Adverse Event Report: DEPUY MITEK LLC US BRISTOW-LATARJET 34MM SCREW,TOP-HAT(1); LIGAMENT ANCHOR

Catalog Number	285126
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	09/23/2015
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 was received and evaluated.Visual observation confirms that the inside of the screw head is damaged indicating the screw was tightened to high torque levels causing the damage.This failure could be attributed to patient¿s bone quality being very hard.A batch review was not conducted as the batch number is unknown.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.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.
Event or Problem Description
It was reported by the customer in (b)(6) that during latarjet surgical procedure, it was observed that the bristow-latarjet 34mm screw,top-hat(1) screw head stripped.According to the reporter, the event occurred while the surgeon was screwing the device into patient's glenoid when the screw head stripped.It was further reported that the surgeon was not able to implant screw any further, but was able to unscrew it out.It was reported that the surgeon had to drill a new hole and implanted a new screw.It was reported that the lot number could not be determined.It was reported that a new hole was created because the surgeon was not confident of where the original hole was located.It was reported that the holes were drilled with a 3.2 drill bit.It was reported that and the patient's bone quality was very hard.It was reported that there was a 15 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 34MM 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: 8241390
• Report Number: 1221934-2018-52755
• Device Sequence Number: 2154639
• Product Code: HWC
• UDI-Device Identifier: 10886705020683
• UDI-Public: 10886705020683
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2015

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: 285126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2015
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1