MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER,2 BUTTON,ADULT,TITANIUM, WAGS PL

Catalog Number	WRX381506V1
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a rivet on the walker's right-sided sliding mechanism "snapped off" during use.The end-user lost his balance and experienced a right-sided fall onto his bathroom floor.Reportedly, the end-user scraped his leg, hit his elbow on a wall, and hit his head on the baseboard during the fall.The end-user was recovering from a recent manipulation procedure to his left knee at the time of the incident and has a history of a left total knee replacement.The end-user went to a local hospital's emergency department (ed) where knee x-rays were obtained.No acute findings were identified and the end-user was discharged home after the ed evaluation.The end-user reports that the incident has extended his post-procedure recovery with additional follow-up with his physicians.The end-user no longer had the walker involved in the incident.No sample was available to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported extension of the end-user's post-procedure recovery with additional follow-up, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a rivet on the walker's right-sided sliding mechanism "snapped off" during use.

• Common Device Name: WALKER,2 BUTTON,ADULT,TITANIUM, WAGS PL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11589303
• Report Number: 1417592-2021-00049
• Device Sequence Number: 14672974
• Product Code: ITJ
• UDI-Device Identifier: 00311917173603
• UDI-Public: 00311917173603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: Lay User/Patient
• Device Catalogue Number: WRX381506V1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other