MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 13X42 130D LT; NAIL, FIXATION, BONE

Model Number 71676627

Device Problems Activation, Positioning or Separation Problem (2906); Packaging Problem (3007)

Patient Problem Perforation (2001)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an internal fixation surgery in which the patient needed a left nail, an intertan 1.5 13x42 130d left nail was selected and implanted, but it did not fit correctly.The nail penetrated through the anterior cortex so it was explanted.Upon inspection, it was noticed that the nail configuration was right, but it had been coloured, marked and boxed as left.The procedure was completed, after 30 min, by using an intertan 1.5 13x44 130d left nail.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The orientation of the device was determined to be incorrect according to it labeling.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the attached photos/ label provided support the complaint.Based on the information provided, the surgeon implanted the device that was labeled correct, caused the fracture and they removed and recognized that it was the wrong side.According to the report, the surgeon completed the procedure using an intertan 1.5 13x44 130d left nail with a thirty-minute surgical delay.The impact to the patient beyond the noted perforation fracture cannot be confirmed nor concluded.Should any additional relevant medical information be provided this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the drawing print, the device for the left side should have ¿left¿ laser etch.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device was not in the correct orientation.A potential probable cause could be but is not limited to a mix-up of two orders.Based on this investigation, the need for corrective action is indicated.Through our internal quality process , it was determined that a left nail order and right nail order were mixed up causing the failure.A quality hold was initiated to retrieve the two batches in question.There are also corrective actions being implemented to prevent this issue in the future.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H7, h9: recall reference added.H10.Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The orientation of the device was determined to be incorrect according to it labeling.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the attached photos/ label provided support the complaint.Based on the information provided, the surgeon implanted the device that was labeled correct, caused the fracture and they removed and recognized that it was the wrong side.According to the report, the surgeon completed the procedure using an intertan 1.5 13x44 130d left nail with a thirty-minute surgical delay.The impact to the patient beyond the noted perforation fracture cannot be confirmed nor concluded.Should any additional relevant medical information be provided this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the drawing print, the device for the left side should have ¿left¿ laser etch.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device was not in the correct orientation.A potential probable cause could be but is not limited to a mix-up of two orders prior to colour anodizing.Based on this investigation, the need for corrective action is indicated.As a result of the investigation, several process improvements were implemented related to process monitoring and in process inspection.This event was addressed through a market removal of the product.Containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 13X42 130D LT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14079904
• MDR Text Key: 289054788
• Report Number: 1020279-2022-01785
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556131633
• UDI-Public: 00885556131633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71676627
• Device Catalogue Number: 71676627
• Device Lot Number: 21LT56988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1133-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention