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

Model Number	PS10.0-80D265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
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
Information was received that a revision procedure will be performed due to a broken nail being discovered via x-ray.
Additional Manufacturer Narrative
During evaluation of the given x-ray images, it cannot be determined where the break in the nail occurs.It was reported that the break occurred below the proximal screws, but the x-rays do not clearly show a break or damage to the nail.The proximal screws and a portion of the housing tube were removed during explantation, and the remainder of the nail was removed in a later surgery.Because the proximal portion of the nail was able to be removed from the rest of the nail, it is assumed that the nail was broken prior to explantation, but this cannot be confirmed.No lot number was given, and the nail was scrapped before it was recorded, so the dhr could not be reviewed.The reported surgery for the patient was in 2019 or 2020.This means the nail was implanted for over the indicated time frame of 1 year.Leaving the nail in for over a year increases the risk of bony ingrowths that will make the nail difficult to remove.In addition to probable weight bearing due to the amount of time the nail was implanted, this could explain why the nail reportedly fractured while in-situ and eventually completely broke during explantation.The exact root cause of the reported failure could not be determined, due to there was no device returned.Without the return of the nail, the functional testing and a visual inspection could not be performed.Based on the provided information, it can be confirmed that the nail was broken, but there was no objective evidence found to support the cause for the reported failure mode.The associated risk document was reviewed, and the failure mode, effects, and harms potentially related to the event have been identified and mitigated.The complaint rate is within the estimated rate in the risk documentation associated with this product.There is no new harm or condition associated with the reported event and does not justify the need for new or additional risk evaluation.Furthermore, stryde has been recalled since february 2021 and are currently off the market.Since the product is off the market, no additional action is necessary.
Event or Problem Description
Information was received that a revision procedure will be performed due to a broken nail being discovered via x-ray.A revision was preformed on (b)(6) 2025, to remove the nails.

• Brand Name: PRECICE STRYDE 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, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 21403209
• Report Number: 3006179046-2025-00103
• Device Sequence Number: 20886605
• Product Code: HSB
• UDI-Device Identifier: 00887517951182
• UDI-Public: 887517951182
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS10.0-80D265
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown