MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; HUMERAL INSERTER/EXTRACTOR

Catalog Number 414921

Device Problems Break (1069); Output Problem (3005)

Patient Problem Unspecified Infection (1930)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instrument failure - the patient's original implant became infected and needed to be removed.The surgeon removed the humeral implant and while doing so broke the extractor piece.

Manufacturer Narrative

Mdr 1644408-2022-00951 was reassessed and determined to be non-reportable.This complaint was for an instrument failure and the infection was addressed with mdr 1644408-2022-00952.

Manufacturer Narrative

Manufacturer narrative: the reason for this instrument failure was reported as an infection.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The agent was present during surgery and was able to source a suitable replacement device.The device was not returned to manufacturer and not made available to registered medical assistant (rma) at djo surgical for evaluation.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.Complaint database review showed 10 previous complaint but there were no indications that this instrument has a design or material deficiency.Those are 10 - broke/cracked/damaged.The root cause of this complaint 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 this instrument has a systemic 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 representative stated that the hospital misplaced the device and are unable to locate it.The complaint will be closed, if the device is returned at a later time, an amendment will be created for the investigation.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: HUMERAL INSERTER/EXTRACTOR
• 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: 15153799
• MDR Text Key: 297144360
• Report Number: 1644408-2022-00951
• Device Sequence Number: 1
• Product Code: HWB
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 414921
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• 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