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

Model Number P10.7-80B305

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

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 Description

Information was received that the patient's nail appeared to not be lengthening.A revision procedure was performed in order to create a new osteotomy.The nail still would not lengthen so it was swapped out.The swapped nail was able to lengthen and the patient is doing well.

Manufacturer Narrative

Device evaluation: visual inspection of the returned product showed scratches and dents, and the nail was revealed to be fully retracted.X-ray images of internal components revealed a damaged anti-jam washer.X-ray images on the released work order were also verified and showed no signs of anti-jam washer failure.The length of the nail as received was measured at 302.90 mm.The nail was functionally tested and was unable to distract or retract with the electronic remote controller (erc) and high-speed magnet.As a part of the investigation, the device history records were reviewed and indicated the length of the nail was 303.90 mm at time of manufacture.The difference between the measurement of the nail at time of manufacture and return for complaint was 1mm.The shorter length measured at the time of the complaint investigation indicate that the nail had been retracted.The nail was determined to be jammed due to repeated retraction force from improper use of the erc.The erc unit may have been held in the incorrect orientation during the lengthening sessions causing the device to be retracted instead of being distracted.Device records review: 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 Description

No additional information was provided.

• Brand Name: PRECICE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 12501931
• MDR Text Key: 272889090
• Report Number: 3006179046-2021-00469
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

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
• Device Operator: Health Professional
• Device Model Number: P10.7-80B305
• Device Lot Number: 1021809AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 61 KG