MAUDE Adverse Event Report: ENCORE MEDICAL L.P ENCORE REVERSE SHOULDER HUMERAL SOCKET REAMER, SMALL PF

Catalog Number	804-06-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to fracture.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
He agent reported that (humerus was fractured due to small socket reamer being too large for this female patient.Had to go to size 6mm x 108mm stem and cement it due to fracture from small shell reamer.Female 65).This event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a forty-five-minute 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.Broken/fragmented pieces were left in the patient.Rma examination: the reported instrument was not returned to djo surgical for evaluation.The small humeral socket reamer was left in patient per product feedback form.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.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 thirteen previous complaints but there were no indications that this instrument has a design or material deficiency.The issue in this complaint is not of the instrument but the incorrect size of the reamer used on the patient causing damage to the humerus.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: ENCORE REVERSE SHOULDER HUMERAL SOCKET REAMER, SMALL PF
• Common Device Name: REAMER
• 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: 19102526
• Report Number: 1644408-2024-00458
• Device Sequence Number: 7268656
• Product Code: HTO
• UDI-Device Identifier: 00888912171151
• UDI-Public: 00888912171151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/31/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 804-06-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 113 KG