MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 54; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	804-07-541
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
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 - pieces left in patient.
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported (during case, surgeon took instrument to perform surgery however this broke.Male, 69 ).This event occurred during surgery, near the patient.No response was received 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 not able to source a suitable replacement device.Rma examination: the instrument was not returned to djo for further examination, follow up attempts have been issued with no response.If at a later date the instrument is returned, an amendment will be opened to document any new information 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 6 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 54
• Common Device Name: 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: 18415515
• Report Number: 1644408-2023-01861
• Device Sequence Number: 2933207
• Product Code: PAO
• UDI-Device Identifier: 00190446284420
• UDI-Public: 00190446284420
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-07-541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male