MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 10MM; NAIL, FIXATION, BONE

Model Number 71634010

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

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

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, during an arthroscopy (acl or other) / tibia osteosynthesis, when the locking screw was placed, it was impossible to insert it in the nail cap 10mm.They proceeded to perform different maneuvers to insert the plug but it was not possible, dynamic locking screw was not placed, which was not a cause that prevented the insertion of the plug.The procedure could not be completed, after a non-significant delay (15 minutes).Patient was not harmed as consequence of this problem, patient's health status is stable.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, ¿it was impossible to insert¿ the nail cap using different maneuvers during the tibia osteosynthesis/metanail procedure resulting in a 15 minute surgical delay.Per the complaint form, the procedure was not completed, and the dynamic locking screw was not placed; however, that was not a cause of preventing the insertion of the plug.Reportedly, the event caused no harm to the patient and health status stable.Per the surgical technique, the nail cap is optional.As of the date of this medical investigation, the supporting clinical documentation has not been provided.No clinical factors have been found which would have contributed to the event.Based on the information provided, the patient impact beyond the surgical delay and cannot be determined.No further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.A proper type and size of implant must be selected to insure effective treatment of patients, this has been identified as preoperative planning.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.Factors that could contribute to the reported event include size selected or poor insertion technique.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.H6: health effect - impact code.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The visual inspection revealed several points of fracture and deformation on the threads.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.No clinical factors have been found which would have contributed to the event.Based on the information provided, the patient impact beyond the surgical delay and cannot be determined.No further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that that correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.A proper type and size of implant must be selected to insure effective treatment of patients, this has been identified as preoperative planning.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 procedure, the final inspection includes the verification of part configuration per print and states that parts shall be compared to measured parts according to work instruction, which shows the procedure for measuring pieces with a caliper to ensure the correct slot depth in nail caps.Also, per material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.A review made by the quality engineering team revealed that device history record was thoroughly reviewed, and no discrepancies were found.Furthermore, the complaint part underwent a inspection according to smith and nephew quality inspection plan and passed all inspection requirements, indicating that the part is conforming.The investigation did not uncover any issues or concerns.Additionally, no further complaints have been reported regarding this specific part number or batches, which leads us to conclude that this is an isolated incident.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping or mishandling.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.

Manufacturer Narrative

Corrected data: b5, h10 (after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the procedure could not be completed.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since the procedure was successfully completed, after a non-significant delay (15 minutes), without the nail cap 10mm.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.).

Event Description

It was reported that, during an arthroscopy (acl or other) / tibia osteosynthesis, when the locking screw was placed, it was impossible to insert it in the nail cap 10mm.They proceeded to perform different maneuvers to insert the plug but it was not possible, dynamic locking screw was not placed, which was not a cause that prevented the insertion of the plug.The procedure was completed, after a non-significant delay (15 minutes), without the nail cap 10mm.Patient was not harmed as consequence of this problem, patient's health status is stable.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The visual inspection revealed several points of fracture and deformation on the threads.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.No clinical factors have been found which would have contributed to the event.Based on the information provided, the patient impact beyond the surgical delay and cannot be determined.No further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.A proper type and size of implant must be selected to insure effective treatment of patients, this has been identified as preoperative planning.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 procedure, the final inspection includes the verification of part configuration per print and states that parts shall be compared to measured parts according to work instruction, which shows the procedure for measuring pieces with a caliper to ensure the correct slot depth in nail caps.Also, per material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.A review made by the quality engineering team revealed that the complaint part underwent a inspection according to smith and nephew quality inspection plan and passed all inspection requirements, indicating that the part is conforming.The investigation did not uncover any issues or concerns.Additionally, no further complaints have been reported regarding this specific part number or batches, which leads us to conclude that this is an isolated incident.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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: NAIL CAP 10MM
• 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: 15789216
• MDR Text Key: 303567663
• Report Number: 1020279-2022-04782
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010495723
• UDI-Public: 03596010495723
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71634010
• Device Catalogue Number: 71634010
• Device Lot Number: 21HM11558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Male