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

Model Number	74013401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/28/2021
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, the threaded ends of a non rimmed speed pin 110mm sterile broke and a small amount of metal have been left in the tibial bone of the patient.It is unknown how the procedure was completed, or if there was any delay.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the threaded end of the speed pin broke in the tibial bone leaving ¿a small amount of metal (no more than 5mm in total size)¿ retained in the patient¿s tibia.Reportedly, the procedure was completed with the same device without a significant delay.The requested clinical documentation has not been provided as of the date of this medical investigation.The surgeon is now pre-drilling the pins into the tibia ¿to prevent tips not fracturing during removal at the end of the case¿.The material composition of the speed pin is 431 stainless steel, which is a martensitic, heat treatable grade with high corrosion resistance; however, the device is not manufactured or intended for long-term implantation, therefore, long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage, non-significant surgical delay and the retained (tibial) foreign body during the tka procedure could not be definitively determined.Although unlikely, the potential for corrosion and local irritation/migration of the pin-tip fragment could not be ruled out.No further medical assessment can be rendered at this time.A review of the manufacturing records 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 batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents 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 product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.B5.
Event or Problem Description
It was reported that, during a tka surgery, the threaded ends of a non rimmed speed pin 110mm sterile broke and a small amount of metal (no more than 5mm in total size) have been left in the tibial bone of the patient.Surgery was performed, with a non-significant delay, with the same device.

• 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: 12611732
• Report Number: 1020279-2021-07515
• Device Sequence Number: 1321019
• Product Code: HSX
• UDI-Device Identifier: 00885556071502
• UDI-Public: 00885556071502
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 74013401
• Device Catalogue Number: 74013401
• Device Lot Number: 21ANX0029
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2021
• 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: Required Intervention
• Patient Sex: Unknown