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

Model Number	74013480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during tka surgery, 2 to 3mm from the tip of a nonrim speed pin 65 sterile broke off.On a post-operative x-ray, it was found that there is a foreign body in the femur.The procedure had been finished uneventfully.Current patient health status is unknown.
Event or Problem Description
It was reported that, during tka surgery, 2 to 3mm from the tip of a nonrim speed pin 65 sterile broke off.On a post-operative x-ray, it was found that there was a foreign body in the femur, the broken piece was not planned to be removed because the piece was located deep in the bone.The procedure had been finished uneventfully.Current patient health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the tip is broke off.The broken piece was not returned.The clinical/medical investigation concluded that, this case reports that the nonrim speed pin tip broke during the procedure, and could not be retrieved from the patient as it was located deep in the bone.Based on the limited information provided no clinical factors were found which would have contributed to the reported events.The nonrim speed pin is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.There are no plans to remove the retain tip.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.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: NONRIM SPEED PIN 65 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: 17137108
• Report Number: 1020279-2023-01322
• Device Sequence Number: 5972045
• Product Code: HSX
• UDI-Device Identifier: 00885556070925
• UDI-Public: 00885556070925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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 Model Number: 74013480
• Device Catalogue Number: 74013480
• Device Lot Number: 21CNX0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 07/13/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/28/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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: Male