MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NONRIM SPEED PIN 110 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74013401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: case (b)(4).
Event or Problem Description
It was reported that, after a ukr surgery, it was noticed that the tip of one nonrim speed pin 110 sterile, used in the tibia for a cori case, broke off and 3-4mm were left in the tibial bone.Just noticed on post op x-rays.The procedure had been completed, without any delay, using the same device.Patient's current heath status is good.No further injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation.However, the clinical/medical investigation concluded that, the provided electronic photocopied x-ray images appear to support the complaint, as two radiodensities are noted in the proximal to mid-third of the right tibial shaft and appear to be within the medullary canal as the pins are to be bi-cortical.The cori user manual instructs to: (2) use a surgical drill in reverse (counterclockwise spin rotation), remove each pin.It was communicated that the patient¿s current health status is good.Based on the information provided, a user technique/procedure variance was likely a contributing factor to the reported event.The patient impact includes the retained/embedded non-implantable speed pin tips/fragments in the tibial bone, and it is unlikely that micro-motion will occur as the tips are within the medullary canal.Corrosion, and discomfort cannot be definitively ruled out.No delay or further patient injury was reported due to this issue, as this was noted only in the post-operative imaging.Further patient impact could not be determined.Devices batch numbers were 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 devices, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices for single use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The devices should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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: NONRIM SPEED PIN 110 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: 18522166
• Report Number: 1020279-2024-00132
• Device Sequence Number: 3533810
• Product Code: HSX
• UDI-Device Identifier: 00885556071502
• UDI-Public: 00885556071502
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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
• Device Catalogue Number: 74013401
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown