MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR SQUARE HEADED NAIL; PROSTHESIS, HIP, SEMI-CONSTR, METAL/METAL, RESURF

Model Number 999908

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  Injury  

Event Description

It was reported that, during a bhr surgery, the head of a bhr square headed nail broke off while being removed with a slam hammer, and pieces felt into the patient.Pieces were removed using a jacobs chuck on a drill and a smith and nephew nail was used as a back up device for completing the procedure.A minor delay was reported due to this event.No patient injury was reported.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already reported under report 3005975929-2021-00252, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: BHR SQUARE HEADED NAIL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTR, METAL/METAL, RESURF
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11843183
• MDR Text Key: 251227514
• Report Number: 3005975929-2021-00265
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010504630
• UDI-Public: 03596010504630
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 999908
• Device Catalogue Number: 999908
• Device Lot Number: 20LW15963
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention