MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP 22.5IN-LB TORQUE LIMITING DRIVER; DRIVER, PROSTHESIS

Catalog Number	804-06-009
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
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
Instrument failure - 30 minute delay in surgery.
Additional Manufacturer Narrative
See h4 the agent reported "this was a primary surgery.2 different torque screw drivers broke the set screw in the glenoid.We ended up wasting.5 implants because of this.Female 59 yrs." this event occurred during surgery, near the patient.No response was received by the surgeon.The surgery was completed as intended, with a thirty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the instruments were returned to djo and after further examination, the tips of the torque driver are stripped.None of the implants came back with the instruments.

• Brand Name: RSP 22.5IN-LB TORQUE LIMITING DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• 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: 17981431
• Report Number: 1644408-2023-01530
• Device Sequence Number: 11630533
• Product Code: HWR
• UDI-Device Identifier: 00190446187899
• UDI-Public: 00190446187899
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023
• 2 Devices were Involved in the Event: 1 2

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: 804-06-009
• Device Lot Number: 234456L11 & 300110L20
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2017
• 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: 506-03-126 LOT: 834C2162.; 508-00-001 LOT: 850C1396C.; 508-32-101 LOT: 862C4188.; 508-32-204 LOT: 769P2841.; 508-32-204 LOT: 769P2858.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female