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

Model Number	74013471
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2023
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 surgery, a trial tibia tray was inserted and pinned in place to confirm sizing and rotation.This was noted to just avoid the metal tibial interference screw, so it did not have to be extracted.The anterior rim speed pin 45mm sterile that was drilled contacted the interference screw and snapped, but the retained segment was threaded and buried in bone so was left in place so as not to disrupt any of the proximal metaphyseal bone.It is unknown if surgery was delayed as consequence of the issue.The patient is doing well and has been working with physical therapy twice a week.He continues to have stiffness that improves after exercise; most likely due to his previous knee surgery.X-rays of the right knee demonstrate the total knee arthroplasty prosthesis in good position with no evidence of loosening, osteolysis, or subsidence noted.Good alignment is noted.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per the medwatch form, the retained segment was threaded and buried in the bone; therefore, the segment/foreign body was left in place, as not to disrupt any of the proximal metaphyseal bone.It was communicated that x-rays reveal right knee in good alignment and demonstrates the total knee arthroplasty prosthesis in good position with no evidence of loosening, osteolysis, or subsidence noted.Although the speed pin material composition is 431 stainless steel and has been used in medical implantation devices, the speed pin is manufactured and intended as an externally communicating device and is not approved for long term internal tissue exposure/implantation.Per correspondence, no other complications were noted and the patient is doing well, although some stiffness, ¿likely due to¿ previous knee surgery was noted.Based on the information provided, user technique cannot be ruled out as the contributing factor to the reported event.Since the pin segment is reportedly retained in the patient¿s bone, micro-motion and/or migration is unlikely; however, no conclusion on the impact of the retained, non-implantable foreign body can be established.The patient impact beyond 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 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.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.Reuse may increase the risk of breakage, failure, patient infection, patient injury and revision surgery.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 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: RIM SPEED PIN 45MM 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: 17249122
• Report Number: 1020279-2023-01399
• Device Sequence Number: 5259750
• Product Code: HSX
• UDI-Device Identifier: 00885556069981
• UDI-Public: 00885556069981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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 Model Number: 74013471
• Device Catalogue Number: 74013471
• Device Lot Number: 19JNX0047
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG