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

Model Number 804-06-157

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2021

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 : when impacting in small shell stem, inserter knob broke.More specifically, the threads that thread into stem snapped off.They couldn't be removed, so were left in stem.Poly was still able to fully seat into stem.

Manufacturer Narrative

The reason for this instrument failure was reported as broken inserter knob.The possible time in service for baseplate is 3 years and 1 month from manufactured date.The healthcare professional indicated 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 no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The device was returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument device history records (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 instrument that are related to the reported issue.Complaint database review shows three prior complaints filed against the instruments item number that reports a similar failure.Those are 3 - broke/cracked/damaged.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 threaded tip of the inserter knob is broken off (tip not returned), confirming the complaint.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: ALTIVATE REVERSE, SMALL HUMERAL STEM IMPLANT INSERTER KNOB
• 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: 12694743
• MDR Text Key: 280584117
• Report Number: 1644408-2021-01149
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446269106
• UDI-Public: (01)00190446269106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 804-06-157
• Device Catalogue Number: 804-06-157
• Device Lot Number: 266605L04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 12/31/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female