MAUDE Adverse Event Report: ENCORE MEDICAL L.P SCREW, RETAINING GLENOID HEAD RSP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-00-001

Device Problem No Apparent Adverse Event (3189)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/21/2023

Event Type  Injury  

Event Description

Instrument failure - pieces left in patient.

Manufacturer Narrative

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

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-00119; 508-00-001, s801- device cracked/broke, primary surgery, surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.The reported implant was not returned to djo surgical for evaluation.The implant has been lost or discarded per pc form.No further evaluation can be made for this event.This customer complaint will be closed.

• Brand Name: SCREW, RETAINING GLENOID HEAD RSP
• 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: 18531774
• MDR Text Key: 333087942
• Report Number: 1644408-2023-02027
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024617
• UDI-Public: 00888912024617
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 508-00-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 508-32-103 LOT: 864C6262
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female