MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKOWN QUICK PIN; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74013489
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka procedure, while the quick pin adaptor was being used the speed pin qk connect adapter that was inside, broke.As consequence of this breakage the pin was not able to be pulled out.In addition, the piece will no longer hold any screws.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference number: case (b)(4).
Event or Problem Description
It was reported that, during a tka procedure, while the speed pin qk connect adapter was being used the quick pin that was inside, broke.As consequence of this breakage the pin was not able to be pulled out.In addition, the piece will no longer hold any screws.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device did confirm the stated failure mode.A piece of the mating pin was found to be jammed within the adapter.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKOWN QUICK PIN
• 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: 14777314
• Report Number: 1020279-2022-03081
• Device Sequence Number: 6108235
• Product Code: HSX
• UDI-Device Identifier: 03596010627278
• UDI-Public: 03596010627278
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74013489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 07/19/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/20/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74013489/15BM01362 - SPEED PIN QK CONNECT ADAPTER
• Patient Sex: Unknown