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

Model Number P10.7-80B305

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/13/2022

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 patient noticed rotational spinning.The nail has been explanted.The patient reported experiencing pain.

Manufacturer Narrative

Device evaluation: visual inspection of the returned nail revealed that the housing tube had cracks at the anti-rotation lug or the crown region.The reported rotational spinning is likely due to the broken anti-rotation lug.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The inspection data for the lots of anti-rotation lug and housing tube were reviewed and confirmed the parts met design specifications per the engineering drawings.Based on the provided information and the type of breakage observed, it is likely that the nail broke due to stress generated from weight bearing activities.Device labeling: per the precice instructions for use ¿the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs¿.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

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 Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15125499
• MDR Text Key: 304434567
• Report Number: 3006179046-2022-00235
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 1030903AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 76 KG