MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441147

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that during surgery, while inside the patient, the distal femoral cutting block kept sticking on the valgus alignment guide and was difficult to take apart.Procedure continued with the same device, with a delay of less than 30 minutes and no injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.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 the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the gii mis dcf distal cut blk appear to be excessively worn, which would cause the device not to function as intended.The device shows significant signs of wear/usage.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 complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship between the device and the reported incident was corroborated.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 MIS DCF DISTAL CUT BLK
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11391057
• MDR Text Key: 233949258
• Report Number: 1020279-2021-01673
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497185
• UDI-Public: 03596010497185
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2021

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
• Device Operator: Health Professional
• Device Model Number: 71441147
• Device Catalogue Number: 71441147
• Device Lot Number: 16KM10695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 02/06/2021
• Initial Date FDA Received: 02/28/2021
• Supplement Dates Manufacturer Received: 03/31/2021; 05/28/2021
• Supplement Dates FDA Received: 04/19/2021; 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1