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

Model Number	72203270
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the ball/socket joint at the table attachments end cannot hold the leg in place.No patient injury reported.
Additional 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
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7117468
• Report Number: 3003604053-2017-00335
• Device Sequence Number: 781178
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: (01)00885554024821
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1