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	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during inspection, the welding broke around the end of the impactor for a bhr curved cup introducer.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: a bhr curved cup introducer (part number 90128257, batch number s0711264) has been received for investigation.It was reported that during inspection, the welding broke around the end of the impactor.No case was reported; therefore, there was no patient involvement.A review of the complaint history for the bhr curved cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the curved cup introducer.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.Visual inspection was performed on the instrument.Scratches could be seen across the instrument consistent with surgical use.There was a crack around the welding at the end of the impactor, this confirms the reported complaint.A functional evaluation of the instrument was not performed due to the damage.The root cause of the reported issue could not be determined conclusively.A potential root cause is general wear and tear which would not have existed on the instrument when originally produced and inspected by smith & nephew.The returned instrument part 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 11326264
• Report Number: 3005975929-2021-00081
• Device Sequence Number: 859117
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: S0711264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/14/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1