MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; TRIAL LINER, EMPOWR ACETABULAR, NEUTRAL, 36F

Model Number	803-41-36F
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
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 - trial acetabular liner was cross-threaded due to surgeon error.A replacement was available to complete the surgery.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this instrument failure was reported as surgeon error.The possible time in service for device is 2 years and 4 months from manufactured date.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no 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.The device was returned to the manufacturer and made available at djo surgical for evaluation.A review of 803-41-36f device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.That are - threads damaged/galled.The root cause of this complaint is likely attributable to damage incurred from surgeon error in cross threading.This is not an event associated with a product failure, malfunction, or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo and after further examination, acetabular liner is cross threaded.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR HIP
• Common Device Name: TRIAL LINER, EMPOWR ACETABULAR, NEUTRAL, 36F
• 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15322172
• Report Number: 1644408-2022-01105
• Device Sequence Number: 20134567
• Product Code: FZX
• UDI-Device Identifier: 00190446296287
• UDI-Public: (01)00190446296287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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 Model Number: 803-41-36F
• Device Catalogue Number: 803-41-36F
• Device Lot Number: 324067L09
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male