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

Model Number 10018800

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

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.(b)(6).

Event Description

The following was reported to us.The traction boots were used during a surgery.When fine traction was applied the leather straps on the boots ripped.Due to this malfunction the patient moved considerably on the operating table.The patient was stabilized by the theater team which prevented her from falling off the table.The patient was checked for injuries and no injuries were reported.A new boot was used, which also broke.A third boot was fitted and the operation started.This caused some delay during surgery.Manufacturer reference # (b)(4).

Event Description

Reference (b)(4).

Manufacturer Narrative

We have received the affected product and forwarded it to our supplier for further investigation.The supplier confirmed that this issue occurred due to a manufacturing failure.To little fat was used during the tanning process.This caused cracks in the leather.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: TRACTION BOOTS, 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: 11138657
• MDR Text Key: 228015621
• Report Number: 8010652-2021-00001
• 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: 08/18/2021

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: 10018800
• Device Catalogue Number: 10018800
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other