MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 130D; NAIL, FIXATION, BONE

Catalog Number 71675384

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, during nail fixation surgery when checking the alignment outside the patient and the intertan 10s 10mm x 18cm 130d nail was connected to the 130d guide, the lag screw drill was attempted to target/pass the nail hole, but it was not possible because the tip of the lag screw drill hit the nail.After changing the guide from 130d to 125d, the drill targeted/passed the nail hole and it was confirmed that the mentioned nail does not have a 130d neck angle, but a 125d neck angle.The laser marking on the nail and the part number on the inner/outer label is 71675384(130d).Surgery was completed, after a delay of 5 minutes, by implanting an intertan 11.5mm x 18cm 130d nail instead.However, as there was space, additional reaming was not needed.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the part number on the device matches the chart-stik and the box that the device came in.A review made by the quality engineering team revealed that, it was concluded that the pins were discovered to be undersized.As a result, the pin moves slightly within the snowman feature, but both nails passed the best fit pin.The vision report attached to the production order reveals that one nail had difficulty passing the vision system scan, requiring three attempts before finally succeeding on the fourth try.The report pertains to the failure of the part placement and the inability to verify the parts.A review of complaint history for the part number over 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 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.According with inspection drawing, final inspection includes verification of mating features and size.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include manufacturing process errors.Based on this investigation, the need for corrective action is not indicated.Should 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 18CM 130D
• Type of Device: 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: 18270606
• MDR Text Key: 330675014
• Report Number: 1020279-2023-02388
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71675384
• Device Lot Number: 22HM03203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1