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

Model Number	90128257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005975929-2020-00542
• Device Sequence Number: 3630718
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention