MAUDE Adverse Event Report: ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 508-32-103

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Primary surgery - implant broke during the surgery.

Manufacturer Narrative

The agent reported "(implant broke during the surgery.Half of implant left in the patient.The surgeon is planning on leaving the broken implant in place.Age-67/gender-female)." the returned retaining screw was visually inspected and confirmed that it had fractured (see attached photos), remaining piece was left in the patient as stated by the agent.This event occurred during surgery, near the patient.The components were inspected prior to use.There was another suitable device available, and the incident did not cause a delay in surgery.There was no risk or adverse event reported and the surgery was completed as intended.Surgical components condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure, or issue.No further action is deemed necessary, at this time.The lot number was not reported, therefore; the component 508-32-108 could not be linked to a specific device history record.The retaining screw, 50800001-10 rev g lot 17990 dhr (attached) shows all the parts, 550 pcs., were acceptable.Complaint database review of 508-32-103 could not be performed since the lot number was not reported.Complaint database review showed no previous complaints against item 50800001-10 lot no.17990, across all failure code categories.The root cause for this complaint is that the retaining screw broke during surgery.There are multiple factors, that are outside of the control of djo surgical, which may have contributed to this event.This failure is most likely due to excessive torque beyond the design limits and/or extreme off-axis trajectory that would fracture the retaining screw.

• Brand Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17015127
• MDR Text Key: 316623670
• Report Number: 1644408-2023-00647
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024747
• UDI-Public: 00888912024747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Model Number: 508-32-103
• Device Catalogue Number: 508-32-103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female