MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN 3.2MM X 343MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631436
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an im nailing of proximal femur fracture, four guide pin 3.2mm x 343mm were bending.On obtaining entry point for proximal reamer, guide wires introduced to tip of greater trochanter by hand and bent.Cannulated entry awl was utilised to assist; however, once entry reamer was passed over the guide pin, each guide pin became bent.It is unknown how surgery was completed and how long was delayed as consequence.Patient was not harmed.
Additional Manufacturer Narrative
H10: the information received by the manufacturer has been re-evaluated for mdr reporting and 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: GUIDE PIN 3.2MM X 343MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11617560
• Report Number: 1020279-2021-02713
• Device Sequence Number: 14455386
• Product Code: HSB
• UDI-Device Identifier: 00885556158371
• UDI-Public: 00885556158371
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122170
• 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): 10/05/2021

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: 71631436
• Device Catalogue Number: 71631436
• Device Lot Number: 20JSM0175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1