MAUDE Adverse Event Report: HOLGER ULLRICH FOOT TRACTION BOOTS FOR CHILDREN, PAIR; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 10019100

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

The following was reported.A patient was on an orthopaedic table for a surgery due to fracture of the right femur.The patients foot was in the traction boot.During the operation one of the straps of the boot tore and the leg slipped out of the boot.A nurse was able to catch the leg.No injury was reported due to the issue.The surgery was interrupted, the sterile operation field was renewed and the patient repositioned.Afterwards the surgery was completed by using manual traction.Manufacturer reference# (b)(4).

Manufacturer Narrative

The affected product was returned for further investigation.The product was manufactured in 2014.A more detailed manufacture date is not available.The investigation revealed that the product was frequently cleaned.It cannot be excluded that wearing and aging have contributed to the defect.The strap ripped at a punched hole, which was deformed.Therefore we assume that the product might be pre-damaged when it was used.In the instructions for use (ifu) the user is told to check the product prior to use and not to use or repair a defective product.We assume that a combination of frequent cleaning, aging and wearing has weakened the strap and caused it to rip.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer report (b)(4).

• Brand Name: FOOT TRACTION BOOTS FOR CHILDREN, 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: 10475792
• MDR Text Key: 209179902
• Report Number: 8010652-2020-00017
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10019100
• Device Catalogue Number: 10019100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 20