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

Model Number	72203270
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the hip distractor ball joint cannot hold the patient position.The procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the hip distractor ball joint cannot hold the patient position.A visual inspection was performed and showed the ball joint is worn and there was too much lubricant on the ball joint.This failure is caused by wear from use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.There were no indications that suggest that the device did not meet product specifications upon release into distribution.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: 9789808
• Report Number: 3003604053-2020-00011
• Device Sequence Number: 2874406
• Product Code: HST
• UDI-Device Identifier: 00885554024821
• UDI-Public: 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 02/20/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1