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

Catalog Number	508-00-001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure - pieces left in patient.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2023-02027
• Device Sequence Number: 6779309
• Product Code: PHX
• UDI-Device Identifier: 00888912024617
• UDI-Public: 00888912024617
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 508-00-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 508-32-103 LOT: 864C6262
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female