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 Patient Involvement (2645)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was found broken during a routine efip inspection.No case involved.
Additional Manufacturer Narrative
A cup introducer (90128257, s0703054), was received for investigation.It was reported that the device was found broken during a routine efip inspection.No case involved.Visual inspection noted that there were scratches across the device consistent with surgical use a functional evaluation was performed, which showed that the top of the device was broken off and the device will no longer be able to function.This does confirm the reported complaint a review of the complaint history for the cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup introducer.This will continue to be monitored.As the supplier is no longer in business and that there is no traceability within sap, the manufacturing records for this device cannot be reviewed.However, all the released instruments involved would have met manufacturing specifications at the time of production.Based on the available information and the product evaluation the root cause has been determined as a fracture problem.

• 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10401216
• Report Number: 3005975929-2020-00293
• Device Sequence Number: 19798324
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: S0703054
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1