MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX32CM 125D RT; NAIL, FIXATION, BONE

Model Number	71676552
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was scheduled to have the subtroch lag screw explanted from an intertan originally done (b)(6) 2015.The fracture was healed at this time.The surgeon had difficulty removing the screw and the subtrochanteric driver shaft item 71674068 threaded tip broke off inside of the screw that was removed.No fragments were left in the patient.The surgeon was also attempting to remove the intertan nail, but was not able to remove the nail.The surgeon used a powered cutting wheel to remove some of the proximal intertan nail that was about 15mm proud, prodruding from the patient¿s greater trochanter.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint reports the tip of the subtrochanteric driver shaft broke off inside of the screw that was being removed.Per email communication, there were no fragments left in the patient and no patient injury.It was further reported that no additional information will be provided.Therefore, based on the provided information, no further assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX32CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10411820
• Report Number: 1020279-2020-03965
• Device Sequence Number: 3155693
• Product Code: JDS
• UDI-Device Identifier: 00885556038512
• UDI-Public: 00885556038512
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2021

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 Expiration Date: 05/18/2019
• Device Model Number: 71676552
• Device Catalogue Number: 71676552
• Device Lot Number: 09EM14378
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 08/15/2020
• Supplement Report FDA Received Date: 06/26/2021
• 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