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

Model Number	P10.7-50D230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the right side nail broke while the patient was walking.The patient visited the hospital presenting with pain and was unable to walk.The nail has been explanted.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.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.
Event or Problem Description
Additional information was received that the patient presented with non-union of the osteotomy and lengthening site and severe muscle atrophy.
Additional Manufacturer Narrative
The unit was not returned to nuvasive for investigation.During evaluation of the provided x-ray images it was noted that the housing tube has broken at the middle of the unit.Based on provided x-rays the reported failure mode was confirmed.The unit¿s work order was reviewed and confirmed that the device passed all inspections per the acceptance tests.The manufacturing x-ray analysis did not reveal any anomalies.The inspection data for the lot of housing tube was reviewed and confirmed that the part met design specifications per the engineering drawings.It is not likely the breakage was related to any manufacturing processes or material issues.Although the exact root cause of the confirmed failure mode could not be determined due to no device return, based on the provided information it is possible/probable that the nail broke due to the 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 or fatigue failure.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs¿.
Event or Problem Description
No additional information has been provided.

• 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: 14775295
• Report Number: 3006179046-2022-00207
• Device Sequence Number: 13786594
• Product Code: HSB
• UDI-Device Identifier: 00812258020637
• UDI-Public: 812258020637
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10.7-50D230
• Device Lot Number: A170920-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/06/2022; 08/05/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/01/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 56 KG