MAUDE Adverse Event Report: SUPPORT ARM 176; SUPPORT, ARM

Model Number SUPPORT ARM 176

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

It was reported that the support arm broke.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

Investigation is based on picture received.According to the picture, the support arm broke at the joint nearest to the bracket.The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.The support arm has been successfully tested for mechanical strength and is designed according to standard.It is unknown under which circumstances the support arm broke.

• Brand Name: SUPPORT ARM 176
• Type of Device: SUPPORT, ARM
• MDR Report Key: 10982315
• MDR Text Key: 220652133
• Report Number: 8010042-2020-01180
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 176
• Device Catalogue Number: 6405976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1