MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while inside the patient, the cutting block had a pin broken off of it.All fragments were removed from the patient and procedure continued with the same device, with a delay of less than 30 minutes and without injuries.
Additional Manufacturer Narrative
It was reported that during a tka, the securing pin broke off of the cutting block and became stuck in the femur.All fragments were removed from the patient and procedure continued with the same device, with a delay of less than 30 minutes and without injuries.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As lot information was not made available, device history record review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files that the reported failure was documented appropriately.No medical documents were received for investigation.Since no patient harm is alleged, therefore no further medical assessment can be performed at this time.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
It was reported that during a tka, the securing pin broke off of the cutting block and became stuck in the femur.All fragments were removed from the patient and procedure continued with the same device, with a delay of less than 30 minutes and without injuries.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As lot information was not made available, device history record review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files that the reported failure was documented appropriately.No medical documents were received for investigation.Since no patient harm is alleged, therefore no further medical assessment can be performed at this time.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: it was reported that during a tka, the securing pin broke off of the cutting block and became stuck in the femur.All fragments were removed from the patient and procedure continued with the same device, with a delay of less than 30 minutes and without injuries.The device, used in treatment, was returned for evaluation.A visual inspection of the returned device shows one pin has broken off, and it is not returned.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files that the reported failure was documented appropriately.No medical documents were received for investigation.Since no patient harm is alleged, therefore no further medical assessment can be performed at this time.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII POST REF A/P BLK SZ 6
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10712243
• Report Number: 1020279-2020-05599
• Device Sequence Number: 3907238
• Product Code: HRY
• UDI-Device Identifier: 03596010407351
• UDI-Public: 03596010407351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2021

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: 71440820
• Device Catalogue Number: 71440820
• Device Lot Number: 09GM03259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 01/15/2021; 07/28/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 01/18/2021; 02/06/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention