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

Model Number	P10.7-80V275
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.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 had not been able to distract since the implant procedure.The nail was revised on an unknown date and the planned therapeutic time was extended as a result.No further patient adverse impact was reported.
Additional Manufacturer Narrative
Visual inspection of the returned product showed no visible damage on the nail and it was fully retracted.X-ray images of internal components revealed a damaged split washer/anti-jam washer.A review of the x-ray images on the released work order were also verified and they did not reveal an anti-jam washer failure.The nail was functionally tested and was unable to distract and retract with the electronic remote controller (erc) and high-speed magnet.The force test and stroke test showed no signs of distraction; this indicated that the device was jammed.As part of the investigation, the device history records were reviewed and indicated the length of the nail was 273.78 mm at the time of manufacture.The length of the nail as received was measured at 273.04 mm.The difference between the measurement of the nail at the time of manufacture and return for the complaint was 0.74 mm.The shorter length measured at the time of the complaint investigation indicated that the nail had been retracted.The nail was determined to be possibly jammed due to repeated retraction force from improper use of the erc/fast distractor.The erc/fast distractor unit may have been held in the incorrect orientation during the inspection at the back table/at the treatment sessions causing the device to be retracted instead of being distracted.A review of the dhr documents indicated that the nail was manufactured by the specified requirements at that time and met all of the required quality inspections before shipment.
Event or Problem Description
No additional information was provided.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Visual inspection of the returned product showed no visible damage on the nail and it was fully retracted.X-ray images of internal components revealed a damaged split washer/anti-jam washer.A review of the x-ray images on the released work order were also verified and they did not reveal an anti-jam washer failure.The nail was functionally tested and was unable to distract and retract with the electronic remote controller (erc) and high-speed magnet.The force test and stroke test showed no signs of distraction; this indicated that the device was jammed.As part of the investigation, the device history records were reviewed and indicated the length of the nail was 273.78 mm at the time of manufacture.The length of the nail as received was measured at 273.04 mm.The difference between the measurement of the nail at the time of manufacture and return for the complaint was 0.74 mm.The shorter length measured at the time of the complaint investigation indicated that the nail had been retracted.The nail was determined to be possibly jammed due to repeated retraction force from improper use of the erc/fast distractor.The erc/fast distractor unit may have been held in the incorrect orientation during the inspection at the back table/at the treatment sessions causing the device to be retracted instead of being distracted.A review of the dhr documents indicated that the nail was manufactured by the specified requirements at that time and met all of the required quality inspections before shipment.

• 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: 13368234
• Report Number: 3006179046-2022-00118
• Device Sequence Number: 17152303
• Product Code: HSB
• UDI-Device Identifier: 00887517934864
• UDI-Public: 887517934864
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 03/17/2022

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 Model Number: P10.7-80V275
• Device Lot Number: 001082AAA
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 03/11/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/16/2022; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 50 KG