MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MIS 3.2MM X 45MM RIMMED PIN STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74016465

Device Problem Fracture (1260)

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

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a tka surgery, the mis 3.2mm x 45mm rimmed pin sterile device broke in situ, causing the surgeon to fish out the remaining pin, out from the bone.The procedure was resumed, after a non-significant delay, with an s+n back-up device.No further complications were reported.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the device is fractured.The clinical/medical investigation concluded that, the provided photo was reviewed and confirms the breakage of the pin.However, it does not provide any clinical insight into the reported breakage.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.Per complaint details, the remaining piece was ¿fished out the bone¿ by the surgeon.The procedure was completed after a non-significant delay using a smith and nephew back-up device in the original bone hole.No further complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for speed pins revealed that the speed pin should be aligned with the orientation of the instrument fixation hole and should touch the bone before drilling to avoid pin binding in the block.Also, using a mallet with speed pins must be avoided, as speed pins can bend and bind in blocks.The review of speed pins also revealed that single use devices should not be reused due to risks of breakage, this has been identified as a caution.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 specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.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: MIS 3.2MM X 45MM RIMMED PIN STERILE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16527339
• MDR Text Key: 311127613
• Report Number: 1020279-2023-00492
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556691984
• UDI-Public: 885556691984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74016465
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• 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): Required Intervention