MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE SHOULDER INSTRUMENT; ALTIVATE REVERSE, HUMERAL SOCKET SHELL TRIAL, STANDARD

Model Number	804-06-152
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - while broaching, the shell broke off and the screw remained in stem.
Additional Manufacturer Narrative
Corrected data: correction in lot number.Lot number was change from lot # 224343l01 to lot # 224643l01.Manufacturer narrative: the reason for this complaint was to report while using the instrument in broaching, the shell broke off and screw remained in stem.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 2 minute delay in surgery, however, surgery was completed as intended, there was no risk to the patient and the instrument was inspected prior to surgery and was found to be acceptable.The instrument was returned on (b)(6) 2017.When this incident occurred, the instrument had been in service for approximately 6 months.Examination of the returned humeral socket shell trial shows the screw shaft broken off of at undercut below the head, confirming the complaint.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Review of complaint history indicates: to date, (b)(6) 2017, 30 complaints have been reported against this part number: 10 for a missing retaining clip and 20 for a broken screw.Of the 20 with broken screws, 11 of them are for this lot number.Per (b)(4) the root cause for failure mode broken screw is design: hex drill point and depth not controlled leading to thin wall condition.
Additional Manufacturer Narrative
Correction: final quality assurance check noted: to clerify, the failure happened during broaching.Therefore the screw would have broken off in the broach and not left in the patient.The stem implant is not in place at this point in the surgery.

• Brand Name: ENCORE SHOULDER INSTRUMENT
• Common Device Name: ALTIVATE REVERSE, HUMERAL SOCKET SHELL TRIAL, STANDARD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6546201
• Report Number: 1644408-2017-00308
• Device Sequence Number: 16396585
• Product Code: FZX
• UDI-Device Identifier: 00888912171717
• UDI-Public: (01)00888912171717
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• 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): 10/10/2017

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 Model Number: 804-06-152
• Device Catalogue Number: 804-06-152
• Device Lot Number: 224643L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 09/13/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 08/30/2017; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR