MAUDE Adverse Event Report: SMITH & NEPHEW, INC. QUICK CON DRILL PIN 1/8 X 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74012905
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka performed on (b)(6) 2021 a fragment from a quick connect drill pin 1/8 x 5 was discovered in the ventro-medial tibial region, after a postoperative radiography was performed.A revision surgery took place on (b)(6) 2021 to remove the complete fragment.The patient was not injured beyond the described event.No other complications were reported.
Additional Manufacturer Narrative
Results of investigation: the device was returned for evaluation.A visual inspection of the returned drill pin confirms the device fractured into two pieces.Both pieces were returned for evaluation.The device exhibits signs of significant wear/ usage.A medical investigation was conducted and confirms based on the information provided, the root cause of the reported event was human error/variance in surgical technique.Per the revision op-note, the foreign body (fb=drill bit fragment) was easily identified via fluoroscopy and complete removal of the fb was confirmed via x-ray.The assessed patient impact was the retained drill bit fragment, additional imaging/exposure, and the revision (fb removal) procedure.Further patient impact could not be determined.No further medical assessment is warranted at this time.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this product and failure mode.The manufacturing process of the device did not contribute to the reported event.Possible probable cause could include but not limited the user error/variance in surgical technique.This is a single-use device and should be discarded after use.Also, the angle and pressure of application could cause the material fracture.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: QUICK CON DRILL PIN 1/8 X 5
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-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: 11916873
• Report Number: 1020279-2021-04906
• Device Sequence Number: 14373908
• Product Code: HRY
• UDI-Device Identifier: 03596010556943
• UDI-Public: 03596010556943
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: GM
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2022

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: 74012905
• Device Catalogue Number: 74012905
• Device Lot Number: 19LNX0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 01/19/2022
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 12/23/2021; 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown