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

Catalog Number 72203270

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

It was reported that the device is lacking the ideal amount of lubrication to slide.

Manufacturer Narrative

An evaluation was performed by smith & nephew and could not replicate the customer complaint for the product is lacking the ideal amount of lubrication to slide.A visual inspection was performed and showed no damage to the device.The carriage assembly was functionally tested and performed as intended.When loosening the orange knob to slide the carriage the knob needs to be rotate several times before the carriage will slide smoothly.This device is considered a no problem found.No manufacturing related defects were observed.No further investigation is required.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6221355
• MDR Text Key: 64140067
• Report Number: 3003604053-2017-00003
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1