MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED SCREW 28MM 4.0; PLATE, FIXATION, BONE

Model Number	121828
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that during an fx patella and tendon repair after being placed in the patellar bone, due to multiple fractures, the cannulated screw 28mm 4.0 did not retain enough and was replaced with ultratape and ultrabraid sutures.No delays or injuries were reported.
Additional Manufacturer Narrative
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 has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on a review of the information provided, the surgeon replaced the cannulated screw 28mm 4.0 with ultra-tape and ultrabraid sutures and completed the procedure without delays or injuries.Since no further impact to the patient is anticipated, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information is provided, this case would be re-assessed.The provided product identification information 121828 and 12hm21596 did not match any known release of this part, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the part number over the past 12 months did not reveal similar events for the listed device.The batch number provided is not valid within the system, even though the review was performed and did not reveal similar events.A review of the instructions for use documents for fracture fixation devices, pins, wires revealed in the indications section that the 4.0mm cannulated screws are intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.Additionally, the warnings section revealed that the correct selection of device components is extremely important; the appropriate type and size should be selected for the patient.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.Factors that could contribute to the reported event include alignment, size selected, patient anatomy and/or procedural/user error.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: CANNULATED SCREW 28MM 4.0
• Common Device Name: PLATE, FIXATION, BONE
• 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: 16632682
• Report Number: 1020279-2023-00682
• Device Sequence Number: 7170448
• Product Code: HRS
• UDI-Device Identifier: 03596010064851
• UDI-Public: 03596010064851
• Combination Product (Y/N): N
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 121828
• Device Catalogue Number: 121828
• Device Lot Number: 12HM21596
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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: Required Intervention
• Patient Sex: Unknown