MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACETABULAR, BONE SCREW, 40MM

Model Number	940-00-040
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
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
Complaint - outer ring on the head of the screw broke off during implantation.Product was inspected prior to implanting and appeared normal.Surgeon implanted per usual following surgical technique.Broken outer ring was removed and the screw stayed implanted.
Additional Manufacturer Narrative
The reason for this complaint was reported as the screw being over torqued.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The device was inspected prior to use and were deemed acceptable.The device was left in patient and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.There are no other complaints that allege this issue.The root cause of this complaint is likely due to the screw being over torqued.There are multiple factors that may contribute to the event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.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: EMPOWR ACETABULAR, BONE SCREW, 40MM
• 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: 12464957
• Report Number: 1644408-2021-00977
• Device Sequence Number: 3794516
• Product Code: LPH
• UDI-Device Identifier: 00190446293460
• UDI-Public: (01)00190446293460
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 940-00-040
• Device Catalogue Number: 940-00-040
• Device Lot Number: 149Z1054
• 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: 07/13/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male