MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 46; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number 804-07-461

Device Problem No Apparent Adverse Event (3189)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2023

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

Intrument failure - piece of broken instrument was left in the patient, the dr left it in the patient.

Manufacturer Narrative

The agent reported (piece of broken instrument was left in the patient, the dr left it in the patient.Female, 78) 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 instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the instrument was not returned to djo for further examination, if at a later time the instrument is returned, an amendment will be opened to document any new information.Is a complaint investigation required? yes justification - if no investigation required: a review of 804-07-461 device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed 5 previous complaints but there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.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.

• Brand Name: ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 46
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16456782
• MDR Text Key: 310405210
• Report Number: 1644408-2023-00233
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00190446284376
• UDI-Public: 00190446284376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162024
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 804-07-461
• Device Catalogue Number: 804-07-461
• Device Lot Number: 269569L08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female