MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE ANATOMIC SHOULDER; ALTIVATE ANATOMIC, NON-CANNULATED CENTER DRILL

Model Number	804-07-153
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for this revision surgery was reported as damage incurred from prolonged use and through misuse or rough handling.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The drill has been returned and the distal tip was not made available to djo surgical for examination.A review of the device history record (dhr) revealed, when released for use, met design and manufacturing requirements.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.This event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - surgeon was attempting to drill center peg for non cannulated reamer and the very distal tip broke off in the patient's glenoid.Another instrument tray was available and utilized to complete procedure.Distal tip was not able to be retrieved and was left in place.

• Brand Name: ALTIVATE ANATOMIC SHOULDER
• Common Device Name: ALTIVATE ANATOMIC, NON-CANNULATED CENTER DRILL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9343010
• Report Number: 1644408-2019-01105
• Device Sequence Number: 14206315
• Product Code: KWS
• UDI-Device Identifier: 00190446174578
• UDI-Public: (01)00190446174578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 Model Number: 804-07-153
• Device Catalogue Number: 804-07-153
• Device Lot Number: 220659L03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 85