MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DRILL GUIDE; DRILL GUIDE, TWO PIECE, RSP

Catalog Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the set screw broke off in the implanted baseplate.Surgeon secured the glenosphere implant to the baseplate with the morse taper but was unable to implant the retaining screw because the instrument broke off in the baseplate.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: DRILL GUIDE
• Common Device Name: DRILL GUIDE, TWO PIECE, RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13338220
• Report Number: 1644408-2022-00076
• Device Sequence Number: 14819363
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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 Catalogue Number: 804-03-048
• Device Lot Number: UNKNOWN
• 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: 01/03/2022
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 804-03-042 LOT UNKNOWN; 804-03-051 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male