MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74013480

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problems Perforation (2001); Rupture (2208)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that, a patient who had a previous acl repair underwent a cori assisted tka procedure, and therefore already had a screw in their tibia.During surgery, an adjustable tibia cut guide was adjusted with a nonrim speed pin 65 sterile and the speed pin snapped in half when it hit the acl screw that was in the tibia (the proximal and medial pin hole on the fixation block).Another pin was added to the distal pin hole on the fixation block.The surgeon later used a vice grip and osteotome to remove the threads of the broken pin and the acl screw from the tibia, requiring additional cuts.The procedure was completed robotically, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H10.Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photographs were reviewed and revealed that the device broke into two pieces.The clinical/medical investigation concluded that the provided photos appear to show a fractured speed pin; however, does not provide additional insight into the reported event.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided, user technique with the insertion of the speed pin over the existing tibial screw (anterior cruciate ligament repair) contributed to the pin fracture/lodged distal threading, need for a back-up pin, and lengthy extraction (>30 min) using additional instrumentation.The patient impact included the pin insertion against the existing tibial screw with subsequent pin fracture which required use of a back-up pin along with the lengthy extraction (>30 minutes) of the threaded speed pin remnant and the anterior cruciate ligament screw using additional instrumentation.Reportedly, the patient was not injured as a consequence of this problem, although there may be a bone hole/void from the anterior cruciate ligament screw removal as well as the two speed pins.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 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 device 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 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: NONRIM SPEED PIN 65 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: 18980038
• MDR Text Key: 338619311
• Report Number: 1020279-2024-00619
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556070925
• UDI-Public: 00885556070925
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74013480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization