MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS 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  

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 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

Corrected data: h6 (device code 4003 was previously submitted.The reporter has confirmed this event was not a migration issue, but a mechanical issue).

Event Description

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

Manufacturer Narrative

Additional data: b5, b6, d9, g3, g6, h2, h3, h6, h10.The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the device evaluation.

Event Description

No additional information was provided.

Manufacturer Narrative

Visual inspection revealed no external damage to the returned nail.X-ray images of the internal components showed no damage and revealed the nail to be partially distracted.The nail was functionally tested and was able to distract and retract with the high-speed magnet tool and the external remote controller (erc).The maximum and minimum length were measured giving a total stroke measurement of 82.16 mm, which meets the 83.5±2.0 mm specification.Distraction force testing was measured at 289.25 lbs, which meets =180 lbs specification.With the information available, the reported failure mode could not be confirmed as the nail was found to be meeting specifications as part of this complaint investigation and nothing was found loose in the device.Review of the device history records indicated the unit met all required quality inspections and testing prior to product departure.

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; 101 enterprise #100; aliso viejo 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13695361
• MDR Text Key: 286993632
• Report Number: 3006179046-2022-00141
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K191336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 47 KG