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

Model Number	P10.7-80B335
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient believes there is a problem with the nail because when they used the electronic remote controller (erc) to distract it makes a noise.The issue led to a difference in distraction from the opposite side nail.Upon completing distraction during follow up with the physician, they found that the nail is bent on the side that made the noise.The nail was explanted and exchanged for an interlocking nail.The patient was reported to have been full weight bearing beyond the instructions for use (ifu).
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
Device evaluation: upon receipt of the returned device, visual inspection revealed the housing tube was bent in the middle.The bent housing tube may have impacted the performance of the nail and likely resulted in failure during use.The reported failure has therefore been confirmed.The x-ray images (taken upon return) also confirmed the bending of the housing tube.The x-ray inspection revealed no other internal failure or broken component.The nail was functionally tested and was unable to distract and retract with the external remote controller (erc) and high-speed magnet.The unit has been determined to have been jammed due to the housing tube bending.The bending of the housing tube caused the internal components of the unit to become misaligned which may have led to the jamming.The unit did not pass the functional testing specification.The inspection data for the lot of the housing tube (lot #210325-10) has been reviewed and confirms the part met design specifications per the engineering drawing.Based on the provided information from the physician, as well as the type of bend observed it is likely that the nail became bent as a result of stress generated from patient weight bearing activities.If excess stress or force was applied to the nail due to weight-bearing activities, it's possible that this contributed to the bending of the housing tube.The nail is designed to withstand certain levels of stress and force, but if it is subjected to excessive amounts, it may become damaged or bent.Device labeling: per the precice instructions for use, "the precice intramedullary limb lengthening nail cannot withstand the stresses of full weight bearing for tibia and femur applications.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs".Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

• 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: 16313594
• Report Number: 3006179046-2023-00110
• Device Sequence Number: 5708258
• Product Code: HSB
• UDI-Device Identifier: 00812258020286
• UDI-Public: 812258020286
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: P10.7-80B335
• Device Lot Number: 1062301AAA
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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
• Patient Sex: Male