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

Model Number 72203270

Device Problems Mechanical Problem (1384); Connection Problem (2900)

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

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the ball/socket joint at the table attachments end cannot hold the leg in place.No patient injury reported.

Manufacturer Narrative

An evaluation was performed by smith & nephew and could not confirm the customer complaint for an issue with the ball joint socket.A visual inspection showed the carriage assembly is broken.The assembly is snapped at the base and the traction post is severely bent and detached causing it not to rotate and the bellow (protective cover) is torn from the ball joint causing the ball joint to be exposed.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: 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7117468
• MDR Text Key: 94985402
• Report Number: 3003604053-2017-00335
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: (01)00885554024821
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203270
• Device Catalogue Number: 72203270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1