MAUDE Adverse Event Report: ENCORE MEDICAL L. P. REVERSE SHOULDER PROSTHESIS INSTRUMENT; RSP GLENOID HALF-MOON REAMER, SMALL

Catalog Number 804-06-013

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2020

Event Type  malfunction  

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

Instrument failure - due to 1/2 moon reamer blunt.

Manufacturer Narrative

Corrected data: see b.2., d.9., e.1., g.1.& h.3.Manufacturer narrative: the reason for this revision surgery was reported as reamer blunt.Disability or permanent damage was reported.The healthcare professional indicated there was a significant adverse event to the patient.There was a delay in surgery and another suitable device was not available for use.The surgery was completed as intended.The device was returned to manufacturer and device evaluation anticipated but not yet begun at djo surgical for examination.The revision level or lot number was 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 previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 100-functional 1 & 102-dull/worn 1.The event is attributable to the surgeon not inspecting the product prior to surgery.This is not an event associated with a product failure, malfunction or issue.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.There are no indications that these instruments have a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: REVERSE SHOULDER PROSTHESIS INSTRUMENT
• Type of Device: RSP GLENOID HALF-MOON REAMER, SMALL
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11084111
• MDR Text Key: 224529312
• Report Number: 1644408-2020-01263
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912148764
• UDI-Public: (01)00888912148764
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability