MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 13.5MM PILOT NOSE IRH; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71118241
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are no numerical markings visible on the flex reamer ends and nursing often mix up the reamer ends when they are being asked for by the surgeon.Event occurred during surgery, with instruments outside the patient.Procedure was completed with the same device.A surgical delay of 30 min or less was reported.No harm to patient was reported due to this failure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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 the device was not used in the procedure, 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.Internal complaint reference: (b)(4).

• Brand Name: 13.5MM PILOT NOSE IRH
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10518193
• Report Number: 1020279-2020-04531
• Device Sequence Number: 11676579
• Product Code: JDG
• UDI-Device Identifier: 03596010409485
• UDI-Public: 03596010409485
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 71118241
• Device Catalogue Number: 71118241
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1