MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISCOVERY HEXALOBULAR SCREW DRIVER

Catalog Number 414926

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - worn ulna bearing kit.Replaced with new ulna bearing kit e+.Bearing rotation tool broke during procedure.10t hexalobular driver, distal tip broke during procedure.

Manufacturer Narrative

1644408-2021-01319 was reassessed and determined to be non-reportable.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISCOVERY HEXALOBULAR SCREW DRIVER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12902083
• MDR Text Key: 281503020
• Report Number: 1644408-2021-01319
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 414926
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 540-01-001 LOT UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female