MAUDE Adverse Event Report: ENCORE MEDICAL LP ENCORE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD

Model Number	804-06-056
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - quick coupling t-handle broke during removal of 6.5mm bone tap from glenoid.Patient had exceptionally hard bone and caused the connection between the handle" and the shaft broke, causing "handle" to rotate freely around connection to shaft.Threaded impaction handle knob broke between proximal and distal screws during implant insertion.Distal portion of threads are stuck in final implant stem.Break had no effect on mating between poly insert and stem.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as broken t-handle.The possible time in service of the main contributor of this complaint is 3 years and 9 months for trial/implant inserter and 7 years and 9 months for t-handle from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported.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 devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows one prior complaint filed against item number 804-03-019 that reports a similar failure.That was 1 - broke/cracked/damaged.Complaint database review shows ten prior complaints filed against item number 804-06-056 that reports a similar failure.Those are 9 - broke/cracked/damaged and 1 - others.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint cannot be determined with confidence as the instrument was lost before investigational review.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.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 reported instrument was returned to djo, however was lost throughout the process of returning the device to quality.No further investigation can be made.The complaint will be closed.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ENCORE SHOULDER
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 11919120
• Report Number: 1644408-2021-00476
• Device Sequence Number: 19659179
• Product Code: PHX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/21/2021

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: 804-06-056
• Device Catalogue Number: 804-06-056
• Device Lot Number: 240084L02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2017
• 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: 804-03-019 LOT 115325L07
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male