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

Catalog Number	74013471
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka, using a speed pin qk connect adapter, when connecting the threaded pin to the femoral cutting guide, it broke and became stuck in the pin guide.There was no breakage inside the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device is stuck in the pin guide.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 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 device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.E1: initial reporter name and address.
Additional Manufacturer Narrative
D1, d2, d4, g4 have been updated.
Event or Problem Description
It was reported that during a tka, using a speed pin qk connect adapter, when connecting the threaded rim speed pin 45mm sterile to the femoral cutting guide, it broke and became stuck in the pin guide.No pieces fell inside of the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual and functional inspections revealed that the speed pin fractured and is in fact stuck inside the speed pin adapter, which prevents the adapter from being used as intended.The speed pin shows signs of extensive wear and use.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported adverse event.According to the report, no pieces fell inside of the patient and the surgeon was able to complete the procedure without a surgical delay using a smith & nephew back-up device.The impact to the patient was the procedure.Since no harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.The speed pin batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the speed pin adapter, 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 a similar event for the speed pin and multiple similar events for the speed pin adapter over the previous 16 months, but no similar events for the speed pin adapter batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The speed pin adapter is a reusable instrument that can be exposed to numerous surgeries.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The speed pin is a single use device.Therefore, surgical technique, misuse, rough handling and damage from prolonged use of reusable instruments 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.B5: describe event or problem.

• 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: 18166917
• Report Number: 1020279-2023-02259
• Device Sequence Number: 20468350
• Product Code: HSX
• UDI-Device Identifier: 00885556069981
• UDI-Public: 00885556069981
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 74013471
• Device Lot Number: 19AGA0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/14/2023; Not provided; 08/16/2024
• Initial Report FDA Received Date: 11/18/2023
• Supplement Report FDA Received Date: 12/19/2023; 06/25/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPEED PIN QK CONNECT ADAPTER, LOT#:19AGA0001
• Patient Age: 68 YR
• Patient Sex: Female