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

Model Number P8.5-80B275

Device Problem Material Twisted/Bent (2981)

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 bent.

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.

Manufacturer Narrative

Visual inspection of the returned precice nail revealed that the housing tube has bent at the middle of the nail.The work order was reviewed, and has confirmed the device passed all inspections per the acceptance tests.The iqc inspection data for the lot of the housing tube was reviewed and confirmed the parts met design specifications per the engineering drawings.Based on reported event information and review of the type of bend in the nail noted during evaluation, it is probable the nail bent due to excessive load generated from weight-bearing activities.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." a review of manufacturing records found no non-conformances or deviations for the lot and found all devices met all release criteria.

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; 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: 12970788
• MDR Text Key: 282129387
• Report Number: 3006179046-2021-00511
• 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: 01/13/2022

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: 01/11/2022
• 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