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

Model Number P8.5-80B275

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Date 10/16/2021

Event Type  malfunction  

Event Description

Information was received that a revision procedure was performed due to the patient hearing a "sound from the leg" and then experiencing pain.Additionally, it was reported that the nail was broken.

Manufacturer Narrative

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

N/a.

Manufacturer Narrative

Device evaluation: visual inspection of the returned precice nail revealed that the housing tube has broken at the middle of the nail.Manufacturing records were reviewed and confirmed the device passed all inspection criteria.The inspection data for the housing tube lot was reviewed and found that parts met design specifications per the engineering drawings.Based on the reported information provided and the type of breakage observed, it is likely the nail fractured due to stress generated from patient weight bearing activities.Device labeling review: per the precice instructions for use: the precice nail cannot withstand the stresses of full weight bearing or fatigue failure.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs.

• Brand Name: PRECICE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 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: 12969673
• MDR Text Key: 282013504
• Report Number: 3006179046-2021-00510
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020224
• UDI-Public: 812258020224
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P8.5-80B275
• Device Lot Number: 0121610AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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: 40 KG