MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 130D; NAIL, FIXATION, BONE

Model Number	71675386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).(b)(6).
Event or Problem Description
It was reported that, after an internal fixation surgery (unknown date), where a trigen intertan 10s 10mm x 20cm 130degree, a intertan subtrochanteric lag screw 11mm x 90mm and a trigen internal hex captured screw 5.0mm x 35mm were implanted, the trigen intertan 10s 10mm x 20cm 130degree broken inside the patient just above the distal screw hole.It is unknown how this adverse event was treated as well as the current health state of the patient.
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, smith and nephew has not received the device/adequate clinical information; consequently, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.The impact to the patient beyond that which has already be reported is unknown.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.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 did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.The contribution of the device to the reported event could not be corroborated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to excessive forces applied to implant or surgical technique.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 10S 10MM X 20CM 130D
• 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: 12665443
• Report Number: 1020279-2021-07628
• Device Sequence Number: 7759542
• Product Code: JDS
• UDI-Device Identifier: 00885556343692
• UDI-Public: 00885556343692
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 71675386
• Device Catalogue Number: 71675386
• Device Lot Number: 20EM04771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71642235-INT HEX CAP SCR 5.0MM X 35MM; 71678090-INTERTAN SUBTROC LAG 11 X 90; 71642235-INT HEX CAP SCR 5.0MM X 35MM; 71678090-INTERTAN SUBTROC LAG 11 X 90
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown