MAUDE Adverse Event Report: ENCORE MEDICAL L.P. KNEE INSTRUMENT; DRILL BIT, 1/8"

Catalog Number	801-01-020
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint: in the midst of a fixation of the trial component by tibial bone pin, after drilling with 3.2mm drill bit, the drill tip was broken and the fragment remained in the patient medullary cavity.
Additional Manufacturer Narrative
The instrument was returned on (b)(6) 2017.When the reported event occurred the instrument may have been in service for over 11.6 years.The specifics of the event were not provided therefore it could not be determined whether another suitable device was available, delay in surgery, was surgery completed as intended, was risk or adverse event reported or was the instrument inspected prior to surgery.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.The number of previous investigations against this lot number is 1.The summary of complaints is as follows dull/worn 12 complaints; mixed product/label 25 complaints; bent 1 complaint; broke/cracked/damaged 23 complaints; end of life 10 complaints; (blank) 11 complaints.Examination confirmed the tip has broken off.Drill bits sustain bending loads at the fracture sites, most likely from contact against drill guides.This loading pattern is most likely exhibited by the drill bits when minimally invasive surgery (mis) techniques are used.The minimally invasive surgery (mis) technique causes a loading pattern of bending moments as well as torsional forces.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.
Additional Manufacturer Narrative
The instrument was returned on 20 november 2017.When the reported event occurred the instrument may have been in service for over 11.6 years.The specifics of the event were not provided therefore it could not be determined whether another suitable device was available, delay in surgery, was surgery completed as intended, was risk or adverse event reported or was the instrument inspected prior to surgery.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.The number of previous investigations against this lot number is 1.The summary of complaints is as follows dull/worn 12 complaints; mixed product/label 25 complaints; bent 1 complaint; broke/cracked/damaged 23 complaints; end of life 10 complaints; (blank) 11 complaints.Examination confirmed the tip has broken off.Drill bits sustain bending loads at the fracture sites, most likely from contact against drill guides.Microscopic examination of the fracture site does not indicate any material abnormalities that contributed to the fracture.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.

• Brand Name: KNEE INSTRUMENT
• Common Device Name: DRILL BIT, 1/8"
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7072777
• Report Number: 1644408-2017-01079
• Device Sequence Number: 16581922
• Product Code: HTW
• UDI-Device Identifier: 00888912042710
• UDI-Public: (01)00888912042710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/15/2018

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: 801-01-020
• Device Lot Number: 33259L01A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 01/05/2018; 01/12/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/09/2018; 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1