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

Model Number	P10.7-80D305
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation at this time.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during a physiotherapy session, the nail's housing tube cracked at the junction of the housing tube and distraction rod, and the crown of the nail fractured.As per the reporter, there was loss of rotational stability.The nail was removed; there was no further adverse patient impact reported.No additional information is available.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.Device evaluation: upon return, visual inspection of the returned precice nail revealed that the housing tube had cracks at the anti-rotation lug or the crown region.The anti-rotation lug was broken in two pieces.X-ray images of the internal components confirmed the broken anti-rotation lug.Loss of distraction/rotational stability is likely due to broken anti-rotation lug.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.Based on the provided information and the type of observed breakage, it is likely that the nail broke due to stress generated from weight bearing activities.Labeling: 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¿.

• 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: 14681507
• Report Number: 3006179046-2022-00204
• Device Sequence Number: 11921147
• Product Code: HSB
• UDI-Device Identifier: 00812258020668
• UDI-Public: 812258020668
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: P10.7-80D305
• Device Lot Number: 1120335AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 68 KG