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	Perforation (2001)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during trauma surgery, after inserting the guide pin 3.2 mm x 343 mm for an intertan nail, the surgeon noticed that the guide pin was bent.The physician inserted another guide pin 3.2 mm x 343 mm which also bent.There were extra pin holes in the femoral head as a result of the pins bending and the surgeon had to accommodate for the bending guide wires, the holes were not treated.A smith and nephew back up device was available.No delay reported.The patient's outcome is unknown.No further information is available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the pins bent during use and resulted in extra pin holes in the femoral head and a 0-30 minute surgical delay.It was communicated that a s&n backup was available and the extra pin holes were not treated.Per correspondence, the requested clinical documentation and current patient status were unavailable.Based on the limited information provided, the clinical root cause could not be concluded.The patient impact beyond the extra bone holes and the surgical delay could not be determined.Should additional clinically relevant information/documentation become available, then the clinical/medical task may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• 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: 12011194
• Report Number: 1020279-2021-05195
• Device Sequence Number: 4408908
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631436
• Device Catalogue Number: 71631436
• Device Lot Number: 21ASM0351
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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: Required Intervention