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	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - when impacting the final broach in to the canal the knob on the inserter broke at the "dead zone" between thread pitches.This is the second knob that has broken during surgery.
Additional Manufacturer Narrative
Corrected data: see h.4.Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as a broken knob.The possible time in service for baseplate is 4 years from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with a two-to-three-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.The device was returned to manufacturer and evaluated by registered medical assistant (rma) 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 was no non-conforming material report (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows nine prior complaints filed against the instruments' item number that reports a similar failure and two prior complaints against the instruments lot number 8- broke/cracked/damaged & 1- bent.No prior complaints report past instances of these instruments being affected by this failure.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 reported instrument was returned to djo and after further examination, the knob screw of the inserter is broken at the threads, confirming the complaint (all pieces returned).The reported condition could possibly be a result of heavy use, misuse, and wear.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: 12356062
• Report Number: 1644408-2021-00877
• Device Sequence Number: 14610880
• Product Code: PHX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/29/2021

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: 07/28/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 11/04/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/29/2021; 12/29/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male