MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE ANATOMIC SHOULDER; ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 46

Model Number	804-07-461
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - while doing a anatomic total shoulder, surgeon was trialing the 46 (blue) glenoid trial.One of the side pegs broke off.Surgeon removed the trial and elected to leave the broken piece in the glenoid.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as peg side of the glenoid broke off.The possible time in service for the instrument is 4 years and 8 months from manufactured date.The healthcare professional indicated that 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.The devices were returned to the manufacturer and made available at djo surgical for evaluation.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 4 previous complaints but there were no indications that this instrument has a design or material deficiency.Those are - broken, 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 instrument was returned to djo and after further examination, one of the pegs on the glenoid trial broke.

• Brand Name: ALTIVATE ANATOMIC SHOULDER
• Common Device Name: ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 46
• 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: 15888475
• Report Number: 1644408-2022-01615
• Device Sequence Number: 14727390
• Product Code: KWS
• UDI-Device Identifier: 00190446284376
• UDI-Public: (01)00190446284376
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 804-07-461
• Device Catalogue Number: 804-07-461
• Device Lot Number: 269569L08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-25-232 LOT 179442L09
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male