MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CURVED CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90128257

Device Problem Break (1069)

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

Event Date 12/10/2020

Event Type  malfunction  

Event Description

It was reported that the item was found broken.It is unknown when the issue was discovered.It is unknown if there was a delay or if a backup device was available.No patient injuries were reported.

Manufacturer Narrative

A bhr curved cup introducer (90128257, 50803346) was returned for investigation.It was reported that the item was found broken.It is unknown when the issue was discovered.There are visible marks and scratches across the whole length of the device, consistent with surgical use some damage to head.Connecting part(wire mechanism) was broken off the device (has been sent back with the instrument).A functional evaluation could not be performed as part was confirmed to be broken.This confirms the reported complaint.The production records could not be reviewed for the instruments reportedly involved in this incident, due to their age.All the released instruments involved would have met manufacturing specifications at the time of production.Based on the available information, the proposed probable root cause for the failure is that the instrument's problems traced to the device reaching the end of its useful life.Smith and nephew recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No preventative or corrective action has been initiated as a result of this investigation.The device cannot be repaired and will be retained.

• Brand Name: BHR CURVED CUP INTRODUCER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire TN ; UK
• MDR Report Key: 11100527
• MDR Text Key: 224535239
• Report Number: 3005975929-2020-00542
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: 50803346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention