MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6257 XPEDITION HIGH CONFIG; TRANSPORT, PATIENT, POWERED

Catalog Number	625705550002
Medical Device Problem Codes	Unintended System Motion (1430); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	12/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was used to go down the front stairs of a single family residence while it was raining.When the device hit the second step, it started to slip and lost traction, sliding to the third step.The loss of traction caused the weight of the device to tweak the provider's back and pulled him down.Later, the provider complained that his back really hurt.
Event or Problem Description
It was reported that the device was used to go down the front stairs of a single family residence while it was raining.When the device hit the second step, it started to slip and lost traction, sliding to the third step.The loss of traction caused the weight of the device to tweak the provider's back and pulled him down.Later, the provider complained that his back really hurt.
Additional Manufacturer Narrative
As a result of the reported event, a stryker (b)(6) made multiple attempts to gather further information.These attempts included an email communication on january 18th, 2024 and february 1st, 2024.As no response was received, a written email was sent on may 29th, 2024 requesting the customer to respond with the requested information.Based on the information provided in the event description, the stryker (b)(6) determined that the alleged tracks descending too fast was likely not due to a component level defect but due to the user losing control on the wet stairs.Multiple attempts have been made to gather the serial number, further information surrounding the event, and the resolution, with no response received.Should a response be received, this complaint may be reopened and updated accordingly.

• Brand Name: 6257 XPEDITION HIGH CONFIG
• Common Device Name: TRANSPORT, PATIENT, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18504959
• Report Number: 0001831750-2024-00011
• Device Sequence Number: 7900817
• Product Code: ILK
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K222818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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
• Device Catalogue Number: 625705550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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