MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72203272

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

As per reported the patient is a male, he is at early 20s.

Event Description

It was reported that the boot snapped off the holder during a hip arthroscopy while the patient was on traction.No patient injuries were reported.Back-up device was available to complete the surgery.Delay greater than 30 minutes was reported.

Event Description

It was reported that, during a hip arthroscopy, the boot snapped off the holder while the patient was on traction.A back-up device was available to complete the surgery.A delay greater than 30 minutes was reported.No patient injuries were reported.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

Manufacturer Narrative

H10 h3,h6: an evaluation was performed by smith and nephew and could confirm the customer complaint for the boot snapped off the holder while the patient was on traction.A visual inspection was performed and showed the ball joint on the ahtb retrfit kit is severely worn and does not tighten all the way down to lock properly.This device was shipped to the customer on (b)(6) 2016.The root cause is wear from use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• Brand Name: KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8497620
• MDR Text Key: 141459967
• Report Number: 3003604053-2019-00044
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 03596010656346
• UDI-Public: 03596010656346
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR