MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SCANDIMED OPTIGUN; SCANDIMED OPTIGUN AND RATCHET

Catalog Number 419500

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reason for this instrument failure was reported as the early mixture of the cement.The possible time in service for the main contributor of the complaint is unknown form the manufacture date.The healthcare professional indicated this event occurred during surgery near the patient.There was another suitable device available for use.The incident did cause a 20 minute delay in surgery, however, surgery was completed as intended.There was no risk to the patient and the instrument was inspected prior to surgery and was found to be acceptable.The devices were disposed of at hospital and not made available to djo surgical for examination.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 no previous complaints that allege this same issue.The root cause of this complaint is likely due to the early mixture of the cement.This is an event associated with surgical error, not an event associated with product failure, malfunction, or issue.There are no indications that these instruments have a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Instrument failure - one unit of simplex cement was mixed in the optivac cartridge for implantation of total elbow components.The cartridge was then loaded into the cement gun with a small diameter nozzle.When the surgeon to fill the canal with cement, only a small amount was dispensed before the cement stopped coming out of the nozzle and back flowed into the cartridge.The cement got around the plunger and onto the cement gun.

• Brand Name: SCANDIMED OPTIGUN
• Type of Device: SCANDIMED OPTIGUN AND RATCHET
• 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: 12759070
• MDR Text Key: 281335467
• Report Number: 1644408-2021-01190
• Device Sequence Number: 1
• Product Code: KIH
• 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
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 419500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• 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
• Treatment: 600-55-601 LOT 296640L01; 600-99-004 LOT 307323L03
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female