MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 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	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure: the screw on the knob of the inserter sheared off inside of the implanted stem.This prevented the 8mm spacer screw from being inserted into the stem.The stem had to be explanted and a new stem implanted to allow use of the 8mm spacer.
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
The reason for this complaint was reported as the screw on the knob of the inserter sheared off inside of the implanted stem.The possible time in service for baseplate is 5 years and 6 months from manufactured date.The healthcare professional indicated this event occurred during surgery, near the patient.A significant adverse event was reported by the surgeon.The surgery was completed as intended, with a five-minute delay.The instrument was not 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) djo surgical.A review of the instrument's device history records (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 this instrument.Complaint database review shows ten prior complaints filed against the instrument item number that reports a similar failure and one prior complaint against the instruments lot number.Those are 9 - broke/cracked/damaged and 1 - bent.The root cause of this complaint 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 instrument was returned to djo and after further examination, the knob of the implant inserter is broken at the threaded tip.The reported condition of the above instruments could possibly be a result of repeated use, misuse, wear, and care must be taken to avoid compromising their performance.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 L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13590900
• Report Number: 1644408-2022-00272
• Device Sequence Number: 4973917
• Product Code: PHX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/27/2022

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: 179426L02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 530-12-108 LOT 412T1588
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male