MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.0MM CANNULATED SCREW 45MM; PLATE, FIXATION, BONE

Model Number	71103245S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a bimalleolar osteosynthesis the head of a 3.0mm cannulated screw 45mm was split inside of the patient.It was decided to leave the body of the 3.0 mm screw inside of the bone of the patient, due to it gave a rotational stability and reduction to the fracture.Surgery was finished without any surgical delay.Patient was not harmed as consequence of this problem.Patient current health status is stable.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the migration was confirmed.The clinical/medical investigation concluded that, the provided undated, unlabeled x-ray photo confirms the failure.However, the root cause of the reported failure cannot be determined.The implantable screw was left secure inside of the patient¿s bone its possible there is soft tissue irritation from the partially exposed shaft of the screw, but none has been reported at this time.The potential for micro-motion and/ or migration is unlikely.Based on the information provided, the surgery was completed without a surgical delay or harm to the patient because of this event.Since it has been reported the patient is in stable condition, no further acute impact to the patient is assumed but it¿s possible that if this screw is determined to be removed in the future it will add to the difficulty of the removal not having the head of the screw.A review of the complaint history did not reveal additional complaints for the listed device.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 and surgical technique.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.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A picture of the radiograph confirmed that the device was fractured along its head.The socket head of the device was the only part of the device returned.The clinical/medical evaluation concluded that the provided undated, unlabeled x-ray photo confirms the failure.However, the root cause of the reported failure cannot be determined.The implantable screw was left secure inside of the patient¿s bone its possible there is soft tissue irritation from the partially exposed shaft of the screw, but none has been reported at this time.The potential for micro-motion and/ or migration is unlikely.Based on the information provided, the surgery was completed without a surgical delay or harm to the patient because of this event.Since it has been reported the patient is in stable condition, no further acute impact to the patient is assumed but it¿s possible that if this screw is determined to be removed in the future it will add to the difficulty of the removal not having the head of the screw.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant.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 future complaints and investigate as necessary.Additional information: d3 and d8/d9.

• Brand Name: 3.0MM CANNULATED SCREW 45MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12285346
• Report Number: 1020279-2021-06173
• Device Sequence Number: 4732001
• Product Code: HRS
• UDI-Device Identifier: 03596010624000
• UDI-Public: 03596010624000
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 71103245S
• Device Catalogue Number: 71103245S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 10/13/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/23/2021; 10/14/2021
• 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: Required Intervention