MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. LATITUDE EV TOTAL ELBOW ARTHROPLASTY; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	9030375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported the driver was being used with a 10nm torque handle and that the tip of the driver broke off in the head of the screw and was cold welded to the screw head.The tip was not able to be retrieved from the patient.The surgeon proceeded to fold the tab over with the punch on the ulnar cap.No additional patient complications were reported.
Additional Manufacturer Narrative
Note corrections to d9/h3 device was returned to manufacturer.The reported event could be confirmed, since the device was returned and found to be in the condition reported.The device inspection revealed the following: visual inspection: the received hex driver shows signs of intense usage.The drill was found to be broken at the hex tip.The remaining edges of the hex tip are blunt and appear to be slightly twisted.The breakage surface reveals a smooth surface.This confirms a sudden brittle fracture.All these signs are evident enough to suggest that there was an intense usage of the driver including high torsional and bending load which led to a forced fracture.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.As per the dimensional inspection and hardness testing, the returned driver was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to misuse of the device / failure to follow the surgical technique.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported the driver was being used with a 10nm torque handle and that the tip of the driver broke off in the head of the screw and was cold welded to the screw head.The tip was not able to be retrieved from the patient.The surgeon proceeded to fold the tab over with the punch on the ulnar cap.No additional patient complications were reported.

• Brand Name: LATITUDE EV TOTAL ELBOW ARTHROPLASTY
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11767762
• Report Number: 3004983210-2021-00039
• Device Sequence Number: 3438561
• Product Code: JDB
• UDI-Device Identifier: 00846832019991
• UDI-Public: 00846832019991
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 9030375
• Device Lot Number: BA3420244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 NM TORQUE HANDLE PART # 9030391