MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT, HIP DISTR W ACTV HEEL TRACTN BOOT; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72203990

Device Problem Mechanical Jam (2983)

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

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during hip arthroscopy with the active heel traction boot, the patient has been put to sleep and positioned into lateral, lateral attachment with perineal post attached and hip distractor attachment then attached.The surgeon tried to pull and twist the orange handle to manoeuvre the leg attachment which seemed to be stuck.The surgeon unclipped attachment to try and fix whilst unattached, it seemed that the ball and socket joint was fused.The surgeon called warehouse to try and locate another loan unit however none were available.He continued to try with surgeon and orderlies to fix the distractor leg for 30 minutes with no prevail and with no other options available case had to be cancelled.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: KIT, HIP DISTR W ACTV HEEL TRACTN BOOT
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11135570
• MDR Text Key: 226023424
• Report Number: 3003604053-2021-00007
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72203990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1