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

Model Number 72203270

Device Problem Break (1069)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case(b)(4).

Event Description

It was reported that, during the hip distraction process, the metal inner sheath of the fine traction broke off into the threads.It was unable to provide traction using the fine traction black handle.There was a backup device available.A delay of more than 30 min was reported.No patient injury or further complications were reported.

Manufacturer Narrative

The reported device, used in treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a discolored and torn ball joint cover and a missing black cap on the fine positioning cross bar.The threads for the fine positioning crank mechanism had a spring-like metal wire wrapped around the threads between the crank and the boot attachment piece.A functional evaluation found the fine positioning mechanism would not retract away from the bed attachment point direction.The boot attachment freely moved along the threaded shaft until it hit the spring-like piece of metal in the threads.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The complaint was confirmed.Factors that could have contributed include excess use of force inconsistent with normal use.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: 12155901
• MDR Text Key: 261236364
• Report Number: 3003604053-2021-00231
• 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,Followup
• Report Date: 10/12/2021

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
• Device Operator: Health Professional
• Device Model Number: 72203270
• Device Catalogue Number: 72203270
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 10/04/2021
• Supplement Dates FDA Received: 08/31/2021; 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1