MAUDE Adverse Event Report: GLOBUS MEDICAL PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P10.7-50J180
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2025
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
It was reported that the surgeon attempted to recharge the nail; however, in-situ retraction was unsuccessful.Following explantation, an additional retraction attempt was made using the electronic remote controller (erc).The nail exhibited minimal movement, shifting approximately 2 to 3mm back and forth, but failed to fully recharge.As a result, the patient requires another surgery.If the exact same nail can be obtained for the procedure, a new nail will be implanted next week.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): GLOBUS MEDICAL; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: whitney ginter ; 2560 general armistead avenue; audubon, PA 19403 ; 8582005905
• MDR Report Key: 21526524
• Report Number: 3006179046-2025-00106
• Device Sequence Number: 8339519
• Product Code: HSB
• UDI-Device Identifier: 00812258026141
• UDI-Public: 812258026141
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: P10.7-50J180
• Device Lot Number: 3080202AAA
• 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: 02/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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: Unknown