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

Model Number	SDL2-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that tip of the screwdriver broke intraoperatively.There was no patient injury reported.
Additional Manufacturer Narrative
The customer¿s report that the tip of the screwdriver broke was confirmed.Visual inspection revealed the thread tip of the 3.5mm screwdriver, long cannulated was broken.It is likely that the screwdriver experienced high forces and/or were detached incorrectly causing the threads to break.The root cause is likely the unit experienced high forces and/or was detached incorrectly.Review of the device history record for the returned unit confirmed that it met all the required quality inspections.
Event or Problem Description
See updated information in h2, h3, h6 and h10.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9975277
• Report Number: 3006179046-2020-00271
• Device Sequence Number: 19018230
• Product Code: HSB
• UDI-Device Identifier: 00812258029135
• UDI-Public: 812258029135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: SDL2-000
• Device Lot Number: 8110584
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: Other