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 Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Instrument failure - surgeon was malleting instrument correctly and the instrument broke.

Manufacturer Narrative

The reason for this complaint was reported as damage incurred from prolonged use and through misuse of instrument.The possible time in service for baseplate is 9 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended, with a five-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery but was unable to source a suitable replacement device.The device was returned to manufacturer and evaluated by registered medical assistant (rma) 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 were no ncmr's associated with the production of the instruments that are related to the reported issue.Complaint database review shows no prior complaints filed against the instrument's production lot that report a similar failure.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is likely due to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.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 in one piece.Upon further examination a major crack was found and the djo empowr kneetm, punch handle is actually in two pieces.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
• MDR Report Key: 12218163
• MDR Text Key: 265396853
• Report Number: 1644408-2021-00760
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00190446238881
• UDI-Public: (01)00190446238881
• Combination Product (y/n): N
• PMA/PMN Number: K171991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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: 325045L17A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR