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

Model Number	71676627
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2022-01785
• Device Sequence Number: 5277475
• Product Code: JDS
• UDI-Device Identifier: 00885556131633
• UDI-Public: 00885556131633
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 09/27/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/11/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1133-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown