MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CEMENT RESTRICTOR; PLUG, CEMENT SZ. 14.0

Model Number	415-00-140
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure - physician was doing a hemi hip arthroplasty for a hip fracture.Cement restrictors, prep, and insertion tools were on back order at the hospital.We provided physician with teknimed cement instrumentation.The distal metal olive got stuck in the patients femur when placing the clearcut cement restrictor.The physician could not remove the metal olive.The treads connecting the t-handle insertion tool to the metal olive broke.Physician had to leave the cement restrictor and metal olive implanted inside the patient.Djo's smallest cemented system sat proud because the distal stem was touching the metal olive.Physician had to use a competitive system because our cemented stems were too long.
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
Manufacturer narrative: the reason for this incident was reported as the teknimed cement instrumentation getting stuck within the cement restrictor.The healthcare professional indicated this event occurred during treatment, near the patient.Significant adverse event was reported by the surgeon.There was a 2 hour delay in surgery, but the surgery was completed as intended.The device was inspected prior to use and found to be acceptable.The devices were left in patient and not made available to djo surgical for examination.A review of the po receiver show that the reported component used in the surgery, when released for use, met design and manufacturing requirements.There was ncmr#: 53621 associated with the main part 415-00-140, plug cement sz 14.0 which document that out of 100 parts lot, 100 parts were rejected due the packaging having the incorrect ce notified body number on the label, should've been ce0086 instead of ce2797.Later, the rejected parts were determined use as is and accepted after proper justification.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Complaint database review showed no previous complaints that allege this same issue.The root cause of this complaint is due to the teknimed cement instrumentation getting stuck within the cement restrictor.The threads of the t-handle broke and was left within the patient.It is unclear the condition of the instrumentation, it is likely the instrument had damage incurred from misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.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.
Event or Problem Description
Reported incident: physician was doing a hemi hip arthroplasty for a hip fracture.Cement restrictors, prep, and insertion tools were on back order at the hospital.Provided physician with teknimed cement instrumentation.The distal metal olive got stuck in the patients femur when placing the clearcut cement restrictor.The physician could not remove the metal olive.The treads connecting the t-handle insertion tool to the metal olive broke.Physician had to leave the cement restrictor and metal olive implanted inside the patient.Djo's smallest cemented system sat proud because the distal stem was touching the metal olive.Physician had to use a competitive system because our cemented stems were too long.

• Brand Name: CEMENT RESTRICTOR
• Common Device Name: PLUG, CEMENT SZ. 14.0
• 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: 15439588
• Report Number: 1644408-2022-01181
• Device Sequence Number: 20252271
• Product Code: LZN
• UDI-Device Identifier: 00888912023474
• UDI-Public: (01)00888912023474
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032685
• 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): 11/04/2022

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 Expiration Date: 09/30/2022
• Device Model Number: 415-00-140
• Device Catalogue Number: 415-00-140
• Device Lot Number: 7719401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2019
• 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: UNK-SURG LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female