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

Catalog Number 804-06-005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Revision surgery - due to fracture.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

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
• Type of Device: 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
• MDR Text Key: 340103387
• Report Number: 1644408-2024-00458
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912171151
• UDI-Public: 00888912171151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 113 KG