MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR; APPARATUS, TRACTION, NON-POWERED

Catalog Number	72203272
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per reported the patient is a male, he is at early 20s.
Event or Problem Description
It was reported that the boot snapped off the holder during a hip arthroscopy while the patient was on traction.No patient injuries were reported.Back-up device was available to complete the surgery.Delay greater than 30 minutes was reported.
Event or Problem Description
It was reported that, during a hip arthroscopy, the boot snapped off the holder while the patient was on traction.A back-up device was available to complete the surgery.A delay greater than 30 minutes was reported.No patient injuries were reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
Additional Manufacturer Narrative
H10 h3,h6: an evaluation was performed by smith and nephew and could confirm the customer complaint for the boot snapped off the holder while the patient was on traction.A visual inspection was performed and showed the ball joint on the ahtb retrfit kit is severely worn and does not tighten all the way down to lock properly.This device was shipped to the customer on (b)(6) 2016.The root cause is wear from use.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: KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8497620
• Report Number: 3003604053-2019-00044
• Device Sequence Number: 11358857
• Product Code: HST
• UDI-Device Identifier: 03596010656346
• UDI-Public: 03596010656346
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2019

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: 72203272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/14/2019; 09/20/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 06/17/2019; 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR