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

Catalog Number 72203270

Device Problem Device Slipped (1584)

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

Event Date 01/03/2019

Event Type  malfunction  

Event Description

It was reported that, during a hip arthroscopy, the worn knob that holds the boot on the main distractor leg was slipping.The pa held the foot in place while the surgeon completed the procedure.The procedure was completed with the same device.Neither surgical delay nor patient injuries were stated.

Manufacturer Narrative

An evaluation was performed by smith and nephew and could not confirm the customer complaint for the knob was worn that holds the boot on.A visual inspection was performed and showed the universal hip distractor in good condition.Function inspection was performed and showed the knob functioned as intended.The boot did not come loose when tightened all the way down.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
• MDR Report Key: 8281285
• MDR Text Key: 134311374
• Report Number: 3003604053-2019-00008
• 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
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1