MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REVERSE SHOULDER PROSTHESIS; SCREW, LOCKING BONE, RSP, 5X26

Model Number	506-03-126
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
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
Revision surgery due to screw would not lock into plate.
Additional Manufacturer Narrative
Corrected data: see b.5.Manufacturer narrative: the reason for this complaint was to report the screw would not lock into the rsp baseplate during surgery.The device was inspected prior to use and deemed acceptable by the surgical team.A djo agent was present when this occurred, and after another suitable screw was located, the surgery was completed as intended and with no reported delay.The surgeon indicated that this surgical installation failure had the potential to be a significant adverse event.The device was returned to manufacturer and examined by djo surgical.A review of the device history record shows that the screw used in this surgery met design and manufacturing requirements when released for use.There were no nonconforming material reports associated with the screw that may have contributed to the reported event.The screw was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the surgery.No complaints have been filed against any other screws from the same lot.An investigation into customer complaints filed against this part number showed seven instances of screws being "stripped" or having "thread damage" due to user error.The screw was returned to djo for analysis.Inspection by djo's quality control department using inspection sheet is25461 revealed two failed inspection features: visual inspection using a comparator and thread dimensions using a thread gauge.Magnification reveals that the head's threading has damage in at least one location.The location of damaged threading revealed by quality control inspection is consistent with the depth to which the screw is able to be inserted into a baseplate before it gets stuck.The root cause of this complaint is thread damage, caused by the user error of cross-threading during installation.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Primary surgery - the screw would not lock into plate.Opened and used another screw, and it engaged and locked into the baseplate.

• Brand Name: REVERSE SHOULDER PROSTHESIS
• Common Device Name: SCREW, LOCKING BONE, RSP, 5X26
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9434537
• Report Number: 1644408-2019-01232
• Device Sequence Number: 19565577
• Product Code: PHX
• UDI-Device Identifier: 00888912024563
• UDI-Public: (01)00888912024563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• 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): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2025
• Device Model Number: 506-03-126
• Device Catalogue Number: 506-03-126
• Device Lot Number: 834C1624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: Other; Required Intervention
• Patient Age: 66 YR