MAUDE Adverse Event Report: ENCORE MEDICAL L.P. KNEE INSTRUMENT; CUT-GUIDE, EM TIBIA MI

Catalog Number	801-01-650
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
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 - the screw for the high settings is no longer turnable.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was to report the screw for the high settings in no longer turnable.This event occurred at inspection away from the patient.Screw possible time in service is 8.8 years.A significant adverse event was reported.The instrument was inspected prior to surgery and was found to be unacceptable.However, there was another suitable device available, the incident did not cause a delay in surgery and surgery was completed as intended.The devices were returned to djo on (b)(6) 2020 and examined by registered medical assistant (rma) at djo surgical.Examination confirmed the complaint, the screw (tube knob) of the returned guide is stripped/damaged.The reported condition could possibly be a result of repeated use over time, misuse, wear and care must be taken to avoid compromising their performance, refer to the ifu.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 but there were no indications that this instrument has a design or material deficiency.There had been two previous complaints against the reported lot number.Summary of complaints: 8 functional, 4 dull/worn, 3 locking mechanism damaged, 1 seized/galled, 10 threads damaged/galled, 14 bent, 9 broke/cracked/damaged, 1 hardware missing/lost, 1 old style/revision, 4 end of life, 3 inadequate instructions for use, 3 blank.The root cause of this complaint was to report the screw for the high settings in no longer turnable.This event is 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 design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.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.No further action is deemed necessary at this time.

• Brand Name: KNEE INSTRUMENT
• Common Device Name: CUT-GUIDE, EM TIBIA MI
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9963616
• Report Number: 1644408-2020-00371
• Device Sequence Number: 2953309
• Product Code: FZX
• UDI-Device Identifier: 00888912131940
• UDI-Public: (01)00888912131940
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/15/2020

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 Catalogue Number: 801-01-650
• Device Lot Number: 53080L03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other