MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 125D; NAIL, FIXATION, BONE

Model Number	71675385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery to insert a short intertan (intertan 10s 10mm x 20cm 125d) on (b)(6) 2021; on (b)(6) 2021 the bone below the fracture was found to be broken.A new surgery was performed on (b)(6) 2021 to exchange the short intertan (intertan 10s 10mm x 20cm 125d) for a long version.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and a relationship, if any, between the device and the reported incidents could not be corroborated.The clinical/medical investigation concluded that, the two images provided confirms the reported failure as a spiral fracture distal to the nail.Based on the information provided, the root cause of the reported breakage cannot be concluded so procedural variance vs post-operative situation cannot be concluded.It was reported this adverse event was treated by the surgeon exchanging the short intertan for a longer version.However, the causal relationship between the s&n device and the reported issue cannot be confirmed.Consequently, the impact to the patient beyond that which has already been reported cannot be determined.Therefore, no further clinical assessment is warranted at this time based on information provided.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 additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, surgical technique, procedural variance and/or user error.Based on this investigation, the need for corrective action is not indicated.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 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12144709
• Report Number: 1020279-2021-05871
• Device Sequence Number: 3976109
• Product Code: JDS
• UDI-Device Identifier: 00885556343647
• UDI-Public: 00885556343647
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 71675385
• Device Catalogue Number: 71675385
• Device Lot Number: 21AM06889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: Hospitalization; Required Intervention