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

Model Number	P10.7-80D305
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail broke during lengthening.Per the reporter, the nail stopped lengthening after 30mm and it was found via x-rays that the crown in the distal part of the nail housing was broken.No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the nail was returned for evaluation.The reported issue indicated that the nail had broken during lengthening and stopped after 30mm distraction.It was noted that the patient was wheelchair-bound throughout the treatment.Upon visual examination, it was confirmed that the nail was broken as it arrived with a cracked housing tube and broken anti-rotation lug.Additional damage near one of the through holes on the distraction rod was also observed.Patient x-rays were reviewed and confirmed to show a separated crown from the housing tube.X-ray analysis conducted in-house indicated no internal damage.Functional testing was performed using a fast distractor and the nail was able to be distracted.Force testing could not be conducted due to the tester¿s inability to slide onto the housing tube due to the flaring of the housing tube at the device's end.Although it was noted that the patient was bound to a wheelchair throughout the treatment, fractures with this profile indicate some kind of excessive force, typically associated with weight-bearing activities.Device labeling: per the precice instructions for use (ifu), ¿the precice intramedullary limb lengthening nail cannot withstand the stresses of full weight bearing for tibia and femur applications.Patients should utilize external support and/or restrict activities until consolidation occurs.¿ device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.
Event or Problem Description
Additional information has been provided.

• 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: 18136939
• Report Number: 3006179046-2023-00355
• Device Sequence Number: 7437506
• Product Code: HSB
• UDI-Device Identifier: 00812258020668
• UDI-Public: 812258020668
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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 Model Number: P10.7-80D305
• Device Lot Number: 3030104AAA
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 70 KG