MAUDE Adverse Event Report: HOLGER ULLRICH LEG PLATES, PAIR; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 113050A0

Device Problem Fracture (1260)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported to us.At the or table 113002b0 leg plates were attached during the surgery.We've requested the model number of the used leg plates, but not received an answer until now.We assume that the model 113050a0 was attached.A patient was positioned in a prone position.As the patient was transferred into a vertical position, the pads of the leg plates broke under the patients knees.The patient could support her- or himself on her or his legs.No injury of the patient was reported.Manufacturer reference# (b)(4).

Manufacturer Narrative

We assume that a use error has caused this incident and the product was overloaded.According to the intended purpose as described in the instructions for use (ifu) plate pair (1130.50a0) is designed for positioning the legs of a patient immediately before, during and after surgical interventions as well as for examination and treatment.The leg plate pair is designed to carry its share of the maximum load imposed by a patient weighing 200 kg.As the patient was transferred from a horizontal into a vertical position, the mayor part of the patients weight rested on the leg plates.This has caused them to break.The user is warned in the ifu concerning the risks related to overloading as follows: "warn ing! risk of injury due to material failure! the maximum permissible load on the product is 78 kg (39 kg per leg plate).This corresponds to its share of the load imposed by a patient weighing 200 kg." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The following was reported to us.At the or table 113002b0 the leg plates 113050a0 were attached during the surgery.A patient was positioned in a prone position.As the patient was transferred into a vertical position, the pads of the leg plates broke under the patients knees.The patient could support support her- or himself on her or his legs.No injury of the patient was reported.According to the clinic the mayor part of the patients weight was on the leg plates when they broke.The patients weight was said to be 110 kg.Manufactuer reference # (b)(4).

• Brand Name: LEG PLATES, PAIR
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 11945077
• MDR Text Key: 254569005
• Report Number: 8010652-2021-00021
• Device Sequence Number: 1
• Product Code: BWN
• 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: 07/09/2021

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: 113050A0
• Device Catalogue Number: 113050A0
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/09/2021
• Patient Sequence Number: 1
• Treatment: OR TABLE 113002B0 SN (B)(6).; OR TABLE 113002B0 SN (B)(4)
• Patient Outcome(s): Other
• Patient Weight: 110