MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC BEARING ROTATION TOOL

Catalog Number 414952

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

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

Instrument failure - the bearing rotational tool was damaged during bearing insertion.The small metal tab used in rotating poly bearing was bent and subsequently completely broke off.It was recovered and placed in a secure place within the ulner tray and washed/decontaminated.Small metal tab will be shipped back to loaners, along with bearing rational tool.

Manufacturer Narrative

The reason for this instrument failure was reported as bearing broke off.The healthcare professional indicated that this event occurred during surgery, near the patient.There was a 20 minute delay in surgery but the surgery was completed as intended.The device was inspected prior to use and found to be acceptable.The device was not returned to the manufacturer and not made available at djo surgical for evaluation.The revision level or lot number were not reported, therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Complaint database review showed 3 previous complaints but there were no indications that this instrument has a design or material deficiency.Those are 3 - broke/cracked/damaged.The root cause for this complaint cannot be determined with complete confidence as the instrument was not returned for investigational review.It is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.There are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported device was not returned to djo surgical for evaluation.The agent stated that the items were discarded.If at a later time the device is returned an amendment will be opened.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC BEARING ROTATION TOOL
• 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15573069
• MDR Text Key: 302004344
• Report Number: 1644408-2022-01318
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 414952
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female