MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 6.8MM GUIDE BAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90127585

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that, a 6.8mm guide bar bent.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: a guide bar 6.8mm (90127585) was returned for investigation.It was reported that, a guide bar is bent.There are some visible marks and scratches across the device, consistent with surgical use.There is a slight bend in the guide bar, laser marking is worn off and cannot be read.It confirms reported complaint.A review of the complaint history for the guide bar was performed using part number in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.Should the batch number become available at a later date then the dhr task will be re-opened and completed.Based on the available information, the proposed probable root cause for the failure is stress problem.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: 6.8MM GUIDE BAR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11526162
• MDR Text Key: 240951663
• Report Number: 3005975929-2021-00149
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010590190
• UDI-Public: 03596010590190
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90127585
• Device Catalogue Number: 90127585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1