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

Model Number	P12.5-80D335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a precice nail broke in the patient which lead to metallosis.
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 a precice nail broke in the patient which led to metallosis.
Additional Manufacturer Narrative
The investigation revealed that the complaint states that the patient broke their femur while the nail was in-situ.The nail was removed as a part of a normal removal procedure, but the nail broke at the male-female junction into two pieces, with one piece able to be removed while the other was left in the patient.The remaining piece caused metallosis so the femoral canal had to be reamed extensively.The unit is an antegrade femur, 12.5mm x 335mm precice 2 nail (lot # 1012082aaa).The nail was sent back to globus for investigation.The dhr was reviewed with no discrepancies occurring during the manufacturing of the lot.It was measured upon receipt.Visual inspection of the nail confirmed a broken housing tube (pp1988-335, lot # 201124-08) at the male-female junction.No part discoloration was found during the inspection.Pictures attached with the complaint showed that the anti-rotation lug (pp2162-002.Lot # 210118-11) was broken into two pieces.The piece that was removed was not returned for evaluation.The inspection records for the housing tube and anti-rotation lug lots were reviewed with the housing tube lot having a non-conformance for one unit not being anodized.This unit was returned to the vendor, and the rest of the lot was accepted.The unit not being anodized would not have an effect on the nail's mechanical strength.After cleaning/disinfection, x-rays were taken and showed no damage to any of the internal components of the nail.The entire anti-rotation lug was missing, and the crack in the housing tube can be seen on the x-ray.The unit was placed in the stroke test fixture and was able to fully distract and retract.With no anti-rotation lug, the nail would not be able to produce any distraction force, so that testing was not performed.Anti-rotation lug breakages of this pattern suggests that the patient was weight bearing when they fractured their femur while the nail was in-situ.The distraction rod rotating against a broken housing tube and broken anti-rotation lug is the likely cause of wear debris that caused the reported metallosis.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.The rate is within the predicted rate, and no new harm was determined.Complaint rate and risk evaluation reveals that the product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22926465
• Report Number: 3006179046-2025-00120
• Device Sequence Number: 15761944
• Product Code: HSB
• UDI-Device Identifier: 00812258020743
• UDI-Public: 812258020743
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: NL
• PMA/510(K) Number: K141023
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P12.5-80D335
• Device Lot Number: 1012802
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White