MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB UNIVERSAL HIP DISTRACTOR; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72203270

Device Problem Positioning Failure (1158)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

It was reported that during a hip surgery the new boot and the arm did not slide smoothly together.It was very rigid and hard to get traction.A delay grater that 30 minutes was reported and no back up device was available.No patient injuries were reported.

Manufacturer Narrative

B5:event: information updated.H6: 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.

Event Description

It was reported that during a hip surgery the new boot and the arm did not slide smoothly together.It was very rigid and hard to get traction.A delay grater that 30 minutes was reported and no patient injuries were reported.It is unknown how the procedure was completed.

• Brand Name: AHTB UNIVERSAL HIP DISTRACTOR
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8931420
• MDR Text Key: 155546925
• Report Number: 3003604053-2019-00100
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: 00885554024821
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1