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

Model Number	P8.5-80E245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, when the nail was removed a portion of the nail had broken off.No patient injury was reported.
Event or Problem Description
No new information provided.
Additional Manufacturer Narrative
Additional information: d4 (lot number).Correction: b2 (no selections - not applicable), h6 (health effect clinical code and health effect impact code).Manufacturing records were reviewed and found the lot met all release criteria with no discrepancies noted.Visual inspection of the returned precice nail revealed that the housing tube had cracks at the anti-rotation lug (the crown region).The work order was reviewed and confirmed the device passed all inspections.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The inspection data for the lots of anti-rotation lug and housing tube was reviewed and confirmed the parts met design specifications per engineering drawings.Based on the type of breakage observed, the nail likely broke due to stress generated from weight bearing activities.Per precice nail instructions for use: "the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize either 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, suite 100; aliso viejo 92656
• MDR Report Key: 11397130
• Report Number: 3006179046-2021-00166
• Device Sequence Number: 11608424
• Product Code: HSB
• UDI-Device Identifier: 00812258020781
• UDI-Public: 812258020781
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: P8.5-80E245
• Device Lot Number: 8060514AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization