MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR REINFORCEMENT PIN, LARGE, 22MM

Catalog Number	346-22-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to after the doctor implanted the poly he felt like there was excessive bleeding behind the knee when he put the leg in extension.He wanted to remove the poly to evaluate the patient's symptoms.
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
See d4 expiration date, h4, h6, and h11.The agent reported "after dr.Implanted the poly he felt like there was excessive bleeding behind the knee when he put the leg in extension.He wanted to remove the poly to evaluate the patient's symptoms.The reinforcement pin was well fixed in the tibia tray and he could not remove it.He has to cut the pin.F/81." the item was lost/discarded, therefore the reported problem could not be confirmed.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to enovis - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.This event occurred during surgery, near the patient.Significant adverse event was reported.There was a 30-minute delay in surgery, but the surgery was completed as intended.The device was inspected prior to use and found to be acceptable.There was another suitable device.Surgical components condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure, or issue.No further action is deemed necessary at this time.A review of the device history record(s) shows that the reported component(s) used in the surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.This is the 1st complaint against the part/lot number combination across all failure modes.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The surgery was completed successfully.Parent case: the root cause for this complaint is excessive bleeding behind the knee.There are multiple factors that are outside of the control of enovis that may contribute to an event.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR REINFORCEMENT PIN, LARGE, 22MM
• 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: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 23386597
• Report Number: 1644408-2025-01576
• Device Sequence Number: 4927743
• Product Code: JWH
• UDI-Device Identifier: 00190446264095
• UDI-Public: 00190446264095
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/07/2026

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 Catalogue Number: 346-22-101
• Device Lot Number: 171Y1015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 348-22-706 LOT: 4697A1004.; 352-01-106 LOT: 296V1140.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female