MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P8.5-50M165
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during the removal procedure bone was seen around the distal tip of the nail which made the extraction difficult and caused the most distal part to come off during extraction.Part of the nail was left inside the patient's femur.No additional information has been provided.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: a visual inspection of the returned nail has been conducted; the nail is not fully intact.In review of the in-house x-rays and clinical x-rays it was determined that the nail separated at the junction of the lead screw and the lead screw coupler, most likely because of locking pin failure at the time of removal.The bone growth around the distraction rod¿s distal tip held the distraction rod and lead screw in place to the extent that it is likely the locking pin, which locks the lead screw into the lead screw coupler, failed as the device was being removed.The mallet¿s impact force on the removal rod, because the device was stuck at the distal end, most likely overcame the load bearing capability of the locking pin and caused it to fail, allowing the housing tube and internals to separate from the lead screw and distraction rod assembly.It is noted that the bulb sleeve is affixed to distal tip of the distraction rod.The locking pin and split end washer stop were not located within the clinical x-rays and were not returned to nuvasive.Functional testing could not be performed due to the missing distraction rod and lug assembly.The reported event of a portion of the nail being left inside the patient¿s femur was able to be verified via the provided clinical x-ray images.This implant is indicated for a one year implantation time per the instructions for use (ifu), current at the time of implantation.The technique used for this patient involved an implantation time of approximately 4 years, which may be enough time for the intermedullary canal to shrink and harden into bone and thus make it more difficult to remove the implant.Device labeling: "device should be removed after implantation time of no more than one year".

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 17492669
• Report Number: 3006179046-2023-00321
• Device Sequence Number: 7376551
• Product Code: HSB
• UDI-Device Identifier: 00812258028237
• UDI-Public: 812258028237
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: P8.5-50M165
• Device Lot Number: 9030201AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2019
• 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
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 60 KG