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	09/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, while using the nonrim speed pin 110 sterile, a piece broke off in the tibia, and remains embedded in the bone.The procedure was completed, using the same device.No other complications were reported.
Additional Manufacturer Narrative
G2, h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation including the operative report has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The material composition for the nonrim speed pin 110 sterile device is stainless steel 431.The nonrim speed pin is manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.Additionally, it reported, the procedure was completed using the same device without any other reported complications.Per a complaint communication, no post-op symptom or complication has been reported by the patient during follow-up appointments.No further clinical/medical assessment can be rendered currently.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 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 provides complete guidelines for indications, contraindications, warnings and precautions to be aware of preoperative, during surgery or postoperative.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.

• 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: 18139173
• Report Number: 1020279-2023-02233
• Device Sequence Number: 6449266
• Product Code: HSX
• UDI-Device Identifier: 00885556071502
• UDI-Public: 00885556071502
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 74013401
• Device Lot Number: 22FNX0022
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/14/2023
• Date Device Manufactured: 04/03/2023
• 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 Sex: Male
• Patient Weight: 90 KG