MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR KNEE OFFSET PATELLA DRILL GUIDE, LARGE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Model Number 802-05-107

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, the agent reported, (patella drill got wedged into the brand new drill guide on the first hole we tried to put it through.Doc couldn't get it out and we had to open a new pan.This event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a delay of a couple of minutes.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the instrument was returned to djo and after further examination, the drill has been welded into the drill guide causing it to get stuck.Complaint database review showed no previous complaints but there were no indications that this instrument has a design or material deficiency.A review of the instrument's device history record (dhr) could not be performed.After extensive review of the database, a dhr for lot number 388620l02 could not be located.A review of 802-05-103 device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.The root cause of this complaint is likely from surgeon error.This is not an event associated with a product failure, malfunction, or issue.

Event Description

Instrument failure - significant adverse event, patella drill got wedged into the brand new drill guide on the first hole we tried to put it through.Doc couldn't get it out and we had to open a new pan.

• Brand Name: EMPOWR KNEE OFFSET PATELLA DRILL GUIDE, LARGE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16406272
• MDR Text Key: 309869831
• Report Number: 1644408-2023-00220
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00190446365891
• UDI-Public: 00190446365891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212941
• 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
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 802-05-107
• Device Catalogue Number: 802-05-107
• Device Lot Number: 388620L02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 802-05-103 LOT: 326172L05
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male