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

Model Number	PS10.0-50D235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.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 removal, the nail was broken and a portion of the nail remained in the patient's femur despite multiple attempts to extract it.No patient or user harm or adverse impact was reported.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product and provided x-ray confirmed that the nail was broken in two pieces.One part was received for direct investigation and the other part remained in the patient¿s body per the reporter.The reported failure mode has therefore been 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 the housing tube was reviewed and confirmed that the part met design specifications per the engineering drawings.The nail's thickness at the broken region was measured 0.0765 inches which meets the specifications.The nail dimensions met manufacturing assembly specifications.It is not likely the breakage was related to any manufacturing processes or material issues.The nail broke at the location of the screw hole which is the weakest section of the nail, therefore, it is likely that the nail became broken due to forces experienced during the explantation procedure.Based on the provided information, no patient or user harm or adverse impact was reported.Additionally, the nail was implanted more than a year (681 days) which is not recommended per the precice stryde instructions for use.Labeling: "device should be removed after implantation time of no more than one year".Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
Additional information has been provided.

• Brand Name: PRECICE STRYDE 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: 14682164
• Report Number: 3006179046-2022-00205
• Device Sequence Number: 14828581
• Product Code: HSB
• UDI-Device Identifier: 00887517951168
• UDI-Public: 887517951168
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: PS10.0-50D235
• Device Lot Number: 0012411
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SURGICAL PLIERS
• Patient Age: 21 YR
• Patient Sex: Prefer Not To Disclose