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	Hip Fracture (2349)
Date of Event	05/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during intramedullary nailing fixation of an intertrochanteric hip fracture, a total of 5 guide pin 3.2mm x 343mm were noticed to be too soft and deformable.This issue, confirmed by x-rays when the anti-rotation bar was inserted and was noticed to be contacting the tip of the guide pin in the femoral head, led to the intramedullary nail migrating proximally and the guide pin bending during drilling with the compression starter drill and later on with the compression drill.Because of this, it was necessary to remove and reposition both the lag and compression screws.A surgical delay of less than 30 minutes occurred due to this event, but it is unknown if the procedure was concluded with the same guide pins or with backup guide pins.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The device, used in treatment, was returned for evaluation.A visual inspection of the returned guide pin 3.2mm x 343mm confirms the device is bent at the tip of the device leading up to the middle of the device.The device shows signs of significant wear and use.A medical investigation was conducted and confirms based on the information provided the clinical root cause could not be definitively concluded.The user technique could not be ruled out as a potential contributing factor.The surgical technique addresses guide pin use.The patient impact was reportedly the lag and compression screws removal and repositioning.Although no further complications were reported there was a discrepancy regarding a surgical delay (less 30 minutes verses greater 60 minutes).No further clinical assessment could be rendered at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 12010432
• Report Number: 1020279-2021-05182
• Device Sequence Number: 4328776
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 21ASM0356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 05/30/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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