MAUDE Adverse Event Report: SERVO-I; SUPPORT, ARM

Model Number SERVO-I

Device Problem Mechanical Problem (1384)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

It was reported that the support arm broke at the lower end.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: SERVO-I
• Type of Device: SUPPORT, ARM
• MDR Report Key: 12323597
• MDR Text Key: 266601170
• Report Number: 8010042-2021-01986
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1