MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER INSTRUMENT; ALTIVATE REVERSE, SMALL HUMERAL STEM TRIAL INSERTER KNOB

Model Number	804-06-057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
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 - during the broaching portion of the procedure the trial became loose from the handle.When the surgeon tried to tighten the knob it was realized it had broken off in the broach.
Additional Manufacturer Narrative
Additional narrative: see d4; d10; d11; h3.Manufacturer narrative: the reason for this event was due to 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.This event occurred during surgery near the patient.It was reported as a significant adverse event, however, there was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended and the instrument was inspected prior to use and was acceptable.A review of the device history record (dhr) revealed, when released for use, the item met design and manufacturing requirements.Complaint database review showed previous complaints on item 804-06-038 and no previous complaints on item 804-06-057, but there were no indications that these instruments have a design or material deficiency.Summary of complaints: 804-06-038 - finished goods.S102 - dull/worn 1; finished goods.S110 - threads damaged/galled 2 finished goods; s303 - broke/cracked/damaged 2: 804-06-057 - finished goods.S303 - broke/cracked/damaged 1 surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.The reported condition could possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.

• Brand Name: ALTIVATE REVERSE SHOULDER INSTRUMENT
• Common Device Name: ALTIVATE REVERSE, SMALL HUMERAL STEM TRIAL INSERTER KNOB
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 9968396
• Report Number: 1644408-2020-00370
• Device Sequence Number: 16882322
• Product Code: FZX
• UDI-Device Identifier: 00888912648059
• UDI-Public: (01)00888912648059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 804-06-057
• Device Catalogue Number: 804-06-057
• Device Lot Number: 277594L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-038, LOT 178881L04; 804-06-038, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other