MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after internal fixation surgery was performed on an unspecified date, a trigen intertan 11.5mm x 18cm 125 degree device was explanted on (b)(6) 2021.Patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided complaint form supports the complaint.However, smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.Therefore, the root cause of the reported failure could not be confirmed nor concluded.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant medical information be provided, this complaint 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.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, patient condition or loss of sterility.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• Brand Name: INTERTAN 11.5MM X 18CM 125D
• 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: 12835733
• Report Number: 1020279-2021-08247
• Device Sequence Number: 19951341
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675202
• Device Catalogue Number: 71675202
• Device Lot Number: 17LT94514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2017
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown