MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR KNEE; DJO EMPOWR KNEETM, SZ 7, 4-IN-1 CUT BLOCK 2

Catalog Number	800-05-087
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2021
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 - the 4-in-1 cutting blocks are developing rust on surfaces that contact the saw blades.
Additional Manufacturer Narrative
Corrected data : see d.10.Manufacturer narrative : the reason for this instrument failure was reported as a poor quality of material.The possible time in service for baseplate is 9 months from manufactured date.The healthcare professional indicated that this event occurred during inspection, away from 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 unacceptable for use based on its appearance.The devices were not 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 no prior complaints filed against the instruments' item number that reports a similar failure.However, the customer complaint history of the reported devices showed no present trends or on-going issues that are needing review.The root cause for this complaint cannot be determined with confidence as the instrument was not returned for investigational review.It is likely attributable to the exposure of the cut slots to either materials or environments that accelerate the corrosion potential, resulting in oxidation.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 not returned to djo, as it was lost during the process of return.As stated in the attachments, the agency did not use the label provided to ship the instrument therefore it cannot be located at this time.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.The rma process has been revised for better controls.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR KNEE
• Common Device Name: DJO EMPOWR KNEETM, SZ 7, 4-IN-1 CUT BLOCK 2
• 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: 12882829
• Report Number: 1644408-2021-01308
• Device Sequence Number: 14954976
• Product Code: FZX
• UDI-Device Identifier: 00190446255796
• UDI-Public: (01)00190446255796
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/04/2022

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 Catalogue Number: 800-05-087
• Device Lot Number: 341256L06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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: 800-05-086 LOT 341256L05; 800-05-088 LOT 341256L08; 800-05-088 LOT 341256L088
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown