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

Model Number	999908
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005975929-2021-00265
• Device Sequence Number: 4819078
• Product Code: NXT
• UDI-Device Identifier: 03596010504630
• UDI-Public: 03596010504630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 999908
• Device Catalogue Number: 999908
• Device Lot Number: 20LW15963
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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; Other; Required Intervention