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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of the introducer broke as the cup was being put on.No delay reported.No patient injuries reported.A s&n backup was available.
Additional Manufacturer Narrative
It was reported that a piece of the bhr curved cup introducer (part 90128257, lot s0811053) broke as the cup was being put on.No delay or patient injuries reported.An s&n backup was available.As of today, the device and additional information have been requested for this complaint but have not become available.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 for this batch.This will continue to be monitored.In the absence of the device, the production records were reviewed for the device reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10671342
• Report Number: 3005975929-2020-00380
• Device Sequence Number: 2737645
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: S0811053
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1