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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a tka, one (1) mis 3.2mm x 45mm rimmed pin sterile broke in femur cutting block and was retained in the patient body.Part of the pin was retrieved with forceps, but the tip of the pin was retained in the patient.The procedure was resumed, without any delay, using the same device.Current health status of the patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, no clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, no clinical factors were found which would have contributed to the event.Although the device material composition is used in other internal/implantable applications, this speed pin is manufactured and intended to be used as an instrument with short-term internal tissue exposure.The patient impact beyond the retained foreign body with possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered 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 speed pins reveals in caution section 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 in caution that single use devices should not be reused due to risks of breakage.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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device reveals the pin fractured into two pieces.One piece of the device was not returned.A second device was received and reviewed and did not revealed any type of damage.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.The clinical/medical evaluation concluded that per complaint details, the tip of the device broke and was retained in the distal femur, medial side.Reportedly, part of the pin was retrieved with forceps; however, the tip was not recovered.The procedure was resumed without delay or need for a backup device and no patient harm is suspected per correspondence.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, no clinical factors were found which would have contributed to the event.Although the device material composition (431 stainless steel) is used in other internal/implantable applications, this speed pin is manufactured and intended to be used as an instrument with short-term internal tissue exposure.The patient impact beyond the retained foreign body with possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of the instructions for use was performed, and speed pins reveals in caution section 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 in caution that single use devices should not be reused due to risks of breakage.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 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.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the pin fractured into two pieces.One piece of the device was not returned.A second device was received and reviewed and did not revealed any type of damage.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.The clinical/medical evaluation concluded that per complaint details, the tip of the device broke and was retained in the distal femur, medial side.Reportedly, part of the pin was retrieved with forceps; however, the tip was not recovered.The procedure was resumed without delay or need for a backup device and no patient harm is suspected per correspondence.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, no clinical factors were found which would have contributed to the event.Although the device material composition (431 stainless steel) is used in other internal/implantable applications, this speed pin is manufactured and intended to be used as an instrument with short-term internal tissue exposure.The patient impact beyond the retained foreign body with possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of the instructions for use was performed, and speed pins reveals in caution section 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 in caution that single use devices should not be reused due to risks of breakage.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 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.We consider this investigation closed.H11 ¿ corrected data.D3- manufacturer: please note that the email address (b)(6).Com was removed, as it does not correspond to the manufacturing site contact.G2- report source: the correct ones are health professional and company representative only.

• Brand Name: MIS 3.2MM X 45MM RIMMED PIN STERILE
• Common Device Name: 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: 16448581
• Report Number: 1020279-2023-00425
• Device Sequence Number: 17607357
• Product Code: HSX
• UDI-Device Identifier: 00885556691984
• UDI-Public: 885556691984
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2023

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 Catalogue Number: 74016465
• Device Lot Number: 21JNX0039
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 05/17/2023; 07/18/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/18/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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