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

Model Number	P8.5-80D245
Medical Device Problem Codes	Fracture (1260); Unintended System Motion (1430)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the patient felt a click and pain that lasted 24 hours.During a follow-up appointment, the surgeon noticed the nail was shortening and was found to be broken.The nail was removed.However; small pieces of the nail were left in the medullary canal during removal.The surgeon believes the patient was full weight bearing.No patient adverse event was reported.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned precice nail revealed that the housing tube had cracks at the anti-rotation lug or the crown region and the anti-rotation lug was broken at least in two pieces.One piece of the lug was returned with the nail and based on the complaint description the other piece/pieces were left in the patient's medullary canal.No objective evidence has been provided for the pieces left inside the patient.The reported loss of distraction is likely due to the broken anti-rotation lug.Based on provided information and the type of breakage observed, it is likely that the nail broke due to stress generated from weight bearing activities and the surgeon indicated that possibility as well.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¿.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 during manufacturing.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): 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: 14525933
• Report Number: 3006179046-2022-00182
• Device Sequence Number: 17592237
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 812258020606
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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 Expiration Date: 11/30/2022
• Device Model Number: P8.5-80D245
• Device Lot Number: 0122216AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• 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: 04/04/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 52 KG