MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72202682

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that, during a hip arthroscopy, the active heel traction boot failed in a way that caused loss of patient positioning.A back-up device was used to complete the procedure.The surgery was not delayed.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A device history record review was performed and showed no non-conformances or deviations associated with the serial number provided.A review of the complaint history records for the listed part revealed no prior complaints about the listed serial number (b)(4).Possible root causes for the loss of patient positioning is loose velcro padding on the ahtb boot or wear from use.This boot was shipped to the customer on 08/30/2017.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.

Manufacturer Narrative

H10: the device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the active heel traction boot failed.A visual inspection was performed and showed the calf pad is missing however it was observed that the loctite was present and within specifications.The o-rings were also broken.O-rings break if pulled too hard.The o-rings are there to help keep the pad in place while positioning the heel, but once the foot is in and secure, they serve no function.A root cause could not be determined how the calf pads detached or how the o-rings broke while the devices where in use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Factors that are known to contribute to the alleged fault/failure may include wear from use or a velcro failure.This failure mode will be trended to assess for any necessary corrective actions.No manufacturing related defects were observed.

• Brand Name: AHTB ACTIVE HEEL TRACTION BOOT
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9356780
• MDR Text Key: 169021192
• Report Number: 3003604053-2019-00134
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1