MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP SPACER W/RETAINING SCREW

Catalog Number	510-08-000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - the 36 n poly insert would not impact flush on the 8mm spacer used so another poly had to be opened.The first 8mm spacer opened would not sit flush on the stem and the set screw would not thread down into the stem, there was a 30 minute delay in surgery.
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 d2a, d2b, d4, d6a, d10, h4, h6, and h11 the agent reported "the 36 n poly insert would not impact flush on the 8mm spacer used so another poly had to be opened.The first 8mm spacer opened would not sit flush on the stem and the set screw would not thread down into the stem." rma examination: the reported device was lost/discarded, see attached form.This event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.There was a 30-minute delay in surgery, but the surgery was completed as intended.Another suitable device was available.The device was inspected prior to surgery and found acceptable.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) show that the reported component(s) used in the previous 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.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The primary surgery was completed successfully.The root cause is the insert would not impact flush on the 8mm spacer.Likely due to an obstruction or false path that led to the use of a new component(s).This is not an event associated with product failure, malfunction, or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP SPACER W/RETAINING SCREW
• 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: 23059675
• Report Number: 1644408-2025-01315
• Device Sequence Number: 9822725
• Product Code: KWS
• UDI-Device Identifier: 00888912024853
• UDI-Public: 00888912024853
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K111061
• 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): 12/17/2025

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: 510-08-000
• Device Lot Number: 142G1651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 509-00-036 LOT: 378P1850.; 510-08-000 LOT: 142G1651.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male