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

Model Number	TSA4-300-S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a revision procedure was performed due to pullout of the distal locking bolt.During the revision the surgeon performed fixation to the nail with cerclage.
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
No additional information has been provided.
Additional Manufacturer Narrative
Investigation has been conducted using the provided clinical x-rays.The screw has not been returned to for in-person investigation.During the review and evaluation of the provided x-ray images, the reported failure could not be confirmed as the nail was noted to be in place with a single proximal locking screw into the femoral head and the screw was seated properly into the nail/distraction rod without any back out failure.The visible failure, however, is the distal locking screw and distraction rod appear to pass through the distal femoral segment.Additionally, upon further review of the radiographic images , "the intramedullary nail is in place with a single proximal locking screw into the femoral head; there is a single distal locking screw.The oblique osteotomy is approximately 2 cm below the level of the lesser trochanter.The telescoping distal end protrudes approximately 1 cm beyond the proximal portion of the nail.The head of the distal locking screw is abutting the lateral cortex of the femur." due to limited information received, no cause could be determined.The review conducted suggests possible misplacement, implant selection or bone quality as likely cause or contributing factor.Device records review: a review of the device history records (dhr) indicated that the screw was manufactured by the specified requirements at that time and met all the required quality inspections before shipment.
Additional Manufacturer Narrative
Additional data: b5, d4, d6b, h3, h10.
Event or Problem Description
Additional information has been provided.

• Brand Name: PRECICE SCREWS
• 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: 16526477
• Report Number: 3006179046-2023-00157
• Device Sequence Number: 5259438
• Product Code: HSB
• UDI-Device Identifier: 00887517026637
• UDI-Public: 887517026637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/30/2023

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: TSA4-300-S
• Device Lot Number: ABACAF0626
• Was Device Available for Evaluation?: No
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 03/12/2023; 03/23/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/21/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 65 KG