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

Catalog Number	72203270
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8281285
• Report Number: 3003604053-2019-00008
• Device Sequence Number: 16182637
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: 00885554024821
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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 Catalogue Number: 72203270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1