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

Model Number 72203270

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hip arthroscopy procedure, the ball and socket joint on the hip distractor was not holding the foot in place and therefore the foot continuously slips out of place.Procedure was completed with the same device.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).H3, h6: ¿the reported device, used in treatment, was received for evaluation and forwarded to the supplier for additional investigation.There was a relationship found between the returned device and the reported incident.A visual inspection found no issues.A functional evaluation confirmed the boot pivot mount was not holding.A complaint history review concluded this was a repeat event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Based on the serial number of this device, the records show that it was manufactured from june 2015 to july 2015.The complaint was confirmed.The items identified as needing replacement or repair, have been determined to be from normal wear and tear that is the result of frequent use during this items service life.Factors that could have contributed to the reported event include repeat overtightening.No containment or corrective actions are recommended at this time.

• 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: 11782997
• MDR Text Key: 249255457
• Report Number: 3003604053-2021-00178
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203270
• Device Catalogue Number: 72203270
• Device Lot Number: 483336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1