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

Model Number	P8.5-80B275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/16/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
N/a.
Additional 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
• Common Device Name: 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
• Report Number: 3006179046-2021-00510
• Device Sequence Number: 4190375
• Product Code: HSB
• UDI-Device Identifier: 00812258020224
• UDI-Public: 812258020224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 40 KG