MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675501
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation procedure, when drilling distal screw holes, the drill did not target the hole on the intertan 10s 10mm x 26cm 125d left.Surgery was resumed, with a non-significant delay, by drilling manually.No further complications reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided in a subsequent e-mail, this was an alignment issue.According to the report, the surgeon completed the procedure by changing the surgical technique and drilled manually and surgery was completed with a non-significant delay without any other complications.Therefore, no further clinical/medical assessment is warranted at this time.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.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 instructions for use documents for intramedullary nail system revealed reveal in the indications section that sound surgical judgment apply to the intramedullary nailing procedure.Also, the preoperative planning/ surgical technique section, indicates to review the surgical technique for effective surgical procedures.A review of the risk management file 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 surgical technique used, size of device or user/procedural variance.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 10S 10MM X 26CM 125D LEFT
• 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: 14627652
• Report Number: 1020279-2022-02785
• Device Sequence Number: 12031396
• Product Code: JDS
• UDI-Device Identifier: 00885556343746
• UDI-Public: 00885556343746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 71675501
• Device Catalogue Number: 71675501
• Device Lot Number: 22BM00896
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/26/2022
• Date Device Manufactured: 02/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown