MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC SHOULDER INSTRUMENT; ALTIVATE ANATOMIC, CANNULATED CENTER DRILL, 4.8MM

Catalog Number 804-07-149

Device Problems Contamination (1120); Device Emits Odor (1425); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 04/19/2017

Event Type  malfunction  

Event Description

Instrument failure complaint - is reporting that these are the new drill bits for the anatomic.The surgeon has used them in a couple of cases, and he feels they are burning the bone, and they stink and he wants new ones.They leave black debris on the patients glenoid.

Manufacturer Narrative

The reason for this complaint the surgeon felt the drill bits were burning the patient, and wanted new ones.It was reported they leave black debris on the patients glenoid.The lot number was not reported therefore the time in service could not be determined with confidence.This event occurred during inspection away from the patient.There was not another suitable device available, however, the incident did not cause a delay in surgery, the 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 cannulated center drill has not been made available to djo surgical for examination as outlined in sales policy (b)(4) after issuance of the return product receipt (rpr).It has been in excess of 46 days from the date created and the agency did indicate that the instrument would be returned for evaluation.Complaint database review showed that this is the first complaint against part number 804-07-149.Review of the complaint does not indicate that the patient was at risk, or that this instrument has a design or material deficiency.The lot number was not reported, therefore this instrument could not be linked to a specific device history record (dhr).The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned a complaint amendment will be initiated.No containment of inventory required, material or design issues cannot be identified.

Manufacturer Narrative

The instrument(s) were returned on (b)(6)2017.When the reported event occurred the instruments may have been in service for over: (lot# 231143l01) 2.7 months and (lot# 220659l01) 3.6 months.Complaint database review showed no previous complaints and there were no indications that these instruments have a design or material deficiency.A review of the device history records (dhr) revealed no discrepancies or issues with the manufacturing history of these parts.The mechanical project manager tested the cannulated center drills in grade 20 foam, they all cut very well.In comparison to the parts in the customer experience suite (ces) lab, they cut noticeably better.In conclusion, these parts are performing as intended.This event is attributable to damage incurred through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.There are no indications that these instruments have a design or material deficiency therefore no containment of inventory is required.

• Brand Name: ALTIVATE ANATOMIC SHOULDER INSTRUMENT
• Type of Device: ALTIVATE ANATOMIC, CANNULATED CENTER DRILL, 4.8MM
• 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: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6575792
• MDR Text Key: 75621359
• Report Number: 1644408-2017-00355
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00190446174530
• UDI-Public: (01)00190446174530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-07-149
• Device Lot Number: 231143L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1