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

Model Number P10.7-80B275

Device Problems Mechanical Problem (1384); Migration (4003)

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

Event Date 01/29/2022

Event Type  malfunction  

Event Description

Information was received that the nail stopped during the lengthening protocol.Per the reporter, the nail was moving inside the body part.No patient adverse event was reported.

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

Additional information was received that "the thinner part is going inside the thicker part.It is loose".

Manufacturer Narrative

H6 (device code 4003 was previously submitted.The reporter has confirmed this event was not a migration issue, but a mechanical issue).

Manufacturer Narrative

Additional data: b5, h3, h6, h10.Device evaluation: upon return, visual inspection of the nail revealed no external damage.X-ray images of the internal components showed no damage and revealed the nail to have been partially distracted.The nail was functionally tested and was able to distract and retract without any abnormal noise using the high-speed magnet tool and the external remote controller (erc).The length as received was measured at 274.49 mm.The maximum and minimum length were measured at 355.57 mm and 273.12 mm respectively; giving a total stroke measurement of 82.45 mm, which meets the specification.Distraction force testing was measured at 292.40 lbs.Which meets the specification.The reported failure could not be confirmed as the nail was found to be functional and met the specifications.As part of this complaint investigation, there were no loose components found within the nail.Device records review: review of the device history records indicated, the unit met all required quality specifications and testing prior to product departure.

Event Description

No additional information has been provided.

• Brand Name: PRECICE SYSTEM
• Type of Device: 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
• MDR Report Key: 13690369
• MDR Text Key: 286750935
• Report Number: 3006179046-2022-00136
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

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
• Device Operator: Health Professional
• Device Model Number: P10.7-80B275
• Device Lot Number: 1061102AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/09/2022; 04/14/2022
• Supplement Dates FDA Received: 03/11/2022; 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 47 KG