MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL NECK TRIAL STANDARD OFFSET

Model Number	803-21-026
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - surgeon was unable to dislocate hip once trials were in and hip was reduced.Had to break burr the neck trial, dual mobility head and offset insert to dislocate hip.
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
Corrected data: see d.6a & d.6b.Manufacturer narrative: the reason for this instrument failure was reported as surgeon was unable to dislocate hip once trials were in and hip was reduced.The healthcare professional indicated this event occurred during surgery, near the patient.With this incident a delay of 10 minutes prolonged surgery time.The surgery was completed as intended and the instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The components of this surgery are not being returned and were either lost or discarded at the hospital.The revision level or lot number were not reported; therefore, this instrument could not be linked to a specific device history records (dhr) or the actual date of manufacturer could not be determined with confidence.Complaint database review shows zero prior complaints filed against the instruments' item number or lot number.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.It is likely attributable to damage incurred from prolonged use and through 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 that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was not returned to djo, instrument was not returned per the product feedback form.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL NECK TRIAL STANDARD OFFSET
• 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: 15365146
• Report Number: 1644408-2022-01166
• Device Sequence Number: 20548451
• Product Code: FZX
• UDI-Device Identifier: 00888912096270
• UDI-Public: (01)00888912096270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 11/22/2022

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 Model Number: 803-21-026
• Device Catalogue Number: 803-21-026
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 803-15-111 LOT UNKNOWN; 803-15-138 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female