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 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that, for a bhr curved cup introducer, the weld below the impacting surface was broken.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: a bhr curved cup introducer (90128257, s0803095) was returned for investigation.It was reported that the weld below the impacting surface was broken.There are some visible marks and scratches across the device, consistent with surgical use.The head of the introducer is broken (head away from the instrument).It confirms reported complaint.A review of the complaint history for the bhr curved cup introducer was performed using part and batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.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 end of life 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: 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 11452155
• MDR Text Key: 239753182
• Report Number: 3005975929-2021-00134
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0803095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1