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 Bone Fracture(s) (1870); Injury (2348)

Event Date 11/02/2020

Event Type  Injury  

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.A leather strap of a traction boot ripped when tension was applied due to the extension procedure.An already existing fracture line was extended.

Event Description

Manufacturer reference # (b)(4).

Manufacturer Narrative

The affected product was discarded by the clinic and not available for further investigation.It was manufactured in the year 2011.The manufacture date could not be narrowed down any further.This means it was in use for more than 8 years when it failed.We have asked for photos of the damage, but these could not be provided.No pre-damage was recognized prior to use by the user.Without being able to investigate the product, we cannot determine for sure the root cause for the damage.The following root causes might have contributed to the damage.Overload: in the instructions for use, it is stated that the maximum permissible tensile load of the product is 700 newton (n).Maybe the product was loaded with more then the stated maximum permissible tension load which might have contributed to the incident.Material fatigue due to wearing and unsuitable reprocessing.The product was in use for more than 8 years.It cannot be excluded that material fatigue occurred due to the long period of use and frequent cleaning and disinfection.Possibly the material was additionally damaged due to mistakes during cleaning and disinfection.Such mistakes might be e.G.: residues of detergent or disinfectant left on the product, product not wiped dry after cleaning or disinfection or the use of unsuitable cleaning agents and disinfectants.The clinic told that the affected patient is fine and could leave the clinic.The fracture healed.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.H3 other text : device not returned.

• 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: 10884554
• MDR Text Key: 217654815
• Report Number: 8010652-2020-00026
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10018800
• Device Catalogue Number: 10018800
• Device Lot Number: N/A
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other