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	01/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported tha the hip distractor was presenting traction issues with the tightening knob.The surgeon saw it slip.

• 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: 7227953
• Report Number: 3003604053-2018-00018
• Device Sequence Number: 10943490
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: (01)00885554024821
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2018

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: 02/28/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/14/2018; 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1