MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EXPRT REVISION HIP, TAPER BREAKER

Catalog Number	803-95-008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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 - proximal body was cold welded to the distal stem.Tried using the taper breaker to disengage the taper, and the connection between the taper breaker and t handle stripped, causing a 30-minute delay in surgery.
Additional Manufacturer Narrative
See h6 and h11.The agent reported "proximal body was cold welded to the distal stem.We tried using the taper breaker to disengage the taper, and the connection between the taper breaker and t handle stripped." the reported device was not returned to surgical for evaluation.If at a later time the device is returned, an amendment will be opened to evaluate the event.This event occurred during surgery, near the patient.No risk or adverse event was reported.There was a 30 min delay in surgery, and the surgery was completed as intended.The instrument was inspected prior to use and found acceptable.When this event occurred, there was another suitable device available.Surgical devices condition can be determined while being used for its intended purpose.The replacement devices due to handling or prolonged use does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.The instrument could not be linked to a specific device history record (dhr) since the lot number was not reported.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.This event is possibly attributable through prolonged use or rough handling which surgical devices are subjected to.This is not an event associated with a product failure, malfunction or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: EXPRT REVISION HIP, TAPER BREAKER
• 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: 22655069
• Report Number: 1644408-2025-01037
• Device Sequence Number: 21048549
• Product Code: LXH
• UDI-Device Identifier: 00190446155751
• UDI-Public: 00190446155751
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 803-95-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown