MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA DRILL 3.2MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	90127619
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, outside the patient, for a bhr dysplasia drill 3.2mm it was noticed that the drill bit was bent.The procedure was successfully completed without delay using a smith+nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
It was reported that, during a bhr procedure, outside the patient, that a bhr dysplasia drill 3.2mm was bent.The procedure was successfully completed without delay using a smith+nephew back-up device.The instrument would have been used as part of treatment.As of today, the instrument and additional information have been requested for this complaint but have not become available.Without definitive lot numbers a complete complaint history review cannot be performed for the bhr dysplasia drill involved.A review of the complaint history for the bhr dysplasia drill was performed using its part number in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.As no batch numbers were provided for investigation, a manufacturing record review could not be performed.The instrument would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.Without return of the actual instrument or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Potential root causes could be an end of life issue due to the age of the device or misuse of the instrument.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 DYSPLASIA DRILL 3.2MM
• 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: 11793896
• Report Number: 3005975929-2021-00209
• Device Sequence Number: 3854553
• Product Code: NXT
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90127619
• Device Catalogue Number: 90127619
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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: Hospitalization; Required Intervention