MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN FRAME; APPARATUS, TRACTION, NON-POWERED

Catalog Number	3105000100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Compartment syndrome (4888)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure while pulling traction on the operative leg the patient¿s foot and the boot liner fell out of the boot, the surgeon was able to catch the foot and readjusted.A week later, following a left hip scope the patient reports right lower calf pain post-operatively, there are concerns for surgical boot/bed causing compartment syndrome.Patient was brought back for surgery on the affected extremity; additional treatment and therapy were required.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Additional Manufacturer Narrative
The device will not be returned for investigation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient¿s foot and the boot liner fell out of the boot.Probable root cause: process: boa laces routed incorrectly.Use errors.
Event or Problem Description
It was reported that during the procedure while pulling traction on the operative leg the patient¿s foot and the boot liner fell out of the boot, the surgeon was able to catch the foot and readjusted.A week later, following a left hip scope the patient reports right lower calf pain post-operatively, there are concerns for surgical boot/bed causing compartment syndrome.Patient was brought back for surgery on the affected extremity; additional treatment and therapy were required.

• Brand Name: PIVOT GUARDIAN FRAME
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23928063
• Report Number: 0002936485-2025-01033
• Device Sequence Number: 9030299
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Catalogue Number: 3105000100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown