MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO.,LTD ENDURANCE QUAD CANE

Model Number ST802-CBL

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

End user was at a truck stop getting coffee when he started to walk with the quad cane and it snapped in two under the curve of the handle.There was no fall or injury.End user confirmed initial report.He drives the east coast out of michigan and typically pulls a 53' box.He stated that the binson's staff helped him adjust the cane.It was placed at the highest setting and he still felt that it was still too short by about 2 inches.The user is 6'4".He states that the hand grip wore out in the first week of use and he lost one tip within the first month of use.He replaced all tips on the cane but could not give a date of replacement.He denies using the cane as he gets out of the elevated cab of his truck.He did note that some of the terrain he walks on is uneven and "difficult." the cane broke in the outer shaft but reportedly not at the hole that the tightening know passed through.He reported that the break was about 6" below the curve.

• Brand Name: ENDURANCE QUAD CANE
• Type of Device: QUAD CANE
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO.,LTD; no. 66, no. 62, no. 58, no. 52; yu long 3 road, dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• Manufacturer (Section G): COM-BRIDGE INTERNATIONAL CO.,LTD; no. 66, no. 62, no. 58, no. 52; yu long 3 road, dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 16641966
• MDR Text Key: 312513176
• Report Number: 3005739540-2023-00002
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754756913206
• UDI-Public: 754756913206
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: ST802-CBL
• Device Catalogue Number: W1302BL
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White