MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR SLEEVE CUTTER SZ 50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	90127600
Medical Device Problem Codes	Dull, Blunt (2407); Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up inspection process, was noticed that the birmingham hip sleeve cutter size 50 is dull.The procedure was completed using a smith and nephew back up device, with no surgical delay and no injury to the patient.
Additional Manufacturer Narrative
A bhr sleeve cutter size 50 (90127600, 18.231386) was returned for investigation, reported as dull.A visual inspection was performed, which noted small number of marks and scratches across the device, consistent with surgical use.The cutting edges have been dulled, with some being slightly deformed.This confirms the reported complaint.A review of the complaint history for the bhr sleeve cutter 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 were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Based on the available information, the proposed probable root cause for the failure is expected wear.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 SLEEVE CUTTER SZ 50
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10815959
• Report Number: 3005975929-2020-00427
• Device Sequence Number: 11204416
• Product Code: NXT
• UDI-Device Identifier: 03596010533388
• UDI-Public: 03596010533388
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 90127600
• Device Catalogue Number: 90127600
• Device Lot Number: 18231386
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESURFACING FEMORAL HEAD 50MM (74121150); RESURFACING FEMORAL HEAD 50MM (74121150)