MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS PRECICE STRYDE SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	PS10.0-50D235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.Warnings: metallic implants can loosen, fracture, corrode, migrate, or cause pain.
Event or Problem Description
Information was received that x-ray images revealed that the nail broke at the distal proximal screw.As per the reporter, the patient experienced pain in (b)(6) 2019.It is unknown if a revision procedure is planned.
Additional Manufacturer Narrative
Additional information was received and the hospital name and address was updated.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail confirmed the reported failure mode.Due to the nature of the breakage observed, the broken ends are not straight but rather stretched.This could indicate that the nail was subjected to excessive bending, rendering it softer and resulting in its breakage.The location of the failure (at the two holes on either sides of the nail) is consistent with what we would expect from a mechanical bending failure in fatigue.The work order was reviewed and confirmed the device passed all inspections and acceptance tests prior to shipment.The type of breakage observed can result from a mechanical bending failure in fatigue due to excessive stress being applied by the patient during daily activities.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections prior to release.
Event or Problem Description
No additional information was provided.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 10171127
• Report Number: 3006179046-2020-00334
• Device Sequence Number: 11298396
• Product Code: HSB
• UDI-Device Identifier: 00887517951168
• UDI-Public: 887517951168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2021

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: PS10.0-50D235
• Device Lot Number: 9020514AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 10/25/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/24/2020; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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 Sex: Unknown