MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR KNEE; DJO EMPOWR KNEETM, 1/8 QUICK CONNECT DRILL BIT

Catalog Number	800-05-022
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - due to the patient receiving a total knee arthroplasty to correct for the advanced stage osteoarthritis and very poor range of motion.During the case, the surgeon preferred to predrill the pin holes using the long 3.2mm drill (catalog # 800-05-022) from the empowr knee trays.The representative suggested the use of the short, hard stop 3.2mm drill bit and was over ruled by the technician.The incident happened while the holes for the tibial baseplate headed pins were being predrilled.The medial hole was drilled and a headed pin was placed through the baseplate.Then the lateral hole was drilled through the baseplate.This is when the drill broke.The surgeon continued to prepare the tibia by reaming and punching through the appropriate guide.Once this was done, the baseplate was removed.The surgeon then looked into the hole where the drill had broken off into.He decided that the drill was too deep into the bone to retrieve.The end result was the drill being left into the cancellous bone of the tibia and the cement mantle being placed proximal to it.The results of the total knee arthroplasty were satisfactory.The surgeon was able to restore mobility to the knee joint and closed the wound without further incidence or delay.
Additional Manufacturer Narrative
The reason for this instrument failure complaint is due to a broken drill bit.This event occurred during surgery.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instrument was inspected prior to surgery and was found to be acceptable.To date the drill bit has not been returned for investigational review as outlined in sales policy (b)(4) after issuance of the return product receipt (rpr).It has been in excess of 52 days from the date created and the agency did indicate that the instrument would be returned for evaluation.The lot number or revision level were not reported, therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Customer complaints review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 7 for broke/cracked/damaged.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.

• Brand Name: EMPOWR KNEE
• Common Device Name: DJO EMPOWR KNEETM, 1/8 QUICK CONNECT DRILL BIT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6943935
• Report Number: 1644408-2017-00864
• Device Sequence Number: 899006
• Product Code: HTW
• UDI-Device Identifier: 00888912408677
• UDI-Public: (01)00888912408677
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 800-05-022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR