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 Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, the ball joint in the "universal hip distractor" could not hold the boot/leg in position.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation and forwarded to the supplier for additional investigation.An analysis of the customer provided images noted a universal hip distractor label with ref 72203270 and s/n: (b)(6) and a worn ball joint.There was a relationship found between the returned device and the reported incident.The product evaluation confirmed the reported failure.The ball joint was damaged and there was low abduction force.The knob spacer, 4 lobe knobs, bellows, and the thrust bearings required replacement.Based on the serial number of this device, the records show that it was manufactured in march 2016.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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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: 11221346
• MDR Text Key: 228441235
• Report Number: 3003604053-2021-00017
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1