MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR POROUS KNEE; DJO EMPOWR KNEETM PUNCH HANDLE

Catalog Number 801-05-040

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

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 - impactor handle broke during case - tibia base plate nothing left inside patient.

Manufacturer Narrative

Manufacturer narrative: the reason for this complaint was reported as impactor handle broke.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported.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 disposed of at hospital and evaluated by registered medical assistant (rma) at 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 this instrument.Complaint database review shows five prior complaints filed against the instruments item number that reports a similar failure.Those are 1 - functional, 3 - broke/cracked/damaged, 1 - device cracked.No prior complaints report past instances of these instruments being affected by this failure.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.It 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 instrument was not returned to djo, and no further evaluation can be made for this event.The rep/agency has been contacted at least three times for the return of this part with no response.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR POROUS KNEE
• Type of Device: DJO EMPOWR KNEETM PUNCH HANDLE
• 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: 12338613
• MDR Text Key: 268462758
• Report Number: 1644408-2021-00868
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00190446238881
• UDI-Public: (01)00190446238881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171991
• 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: 12/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 801-05-040
• Device Lot Number: 170391L01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female