MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441155

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Our reference number: (b)(4).

Event Description

It was reported that, during tka surgery the peg on the genesis ii mis dcf ap ct blk 7 broke off inside the patient.The broken piece was retrieved with a trephine.There was a delay of less than or equal to 30 mins.The procedure was finished with the same device.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports the peg on the cutting block broke inside the patient.Per email correspondence, the broken piece was removed from the patient.The procedure was completed with the same device and there was no patient harm and minimal delay.Therefore, no further clinical assessment is warranted.A visual inspection confirmed one of the posts is broken off the gii mis dcf ap ct blk 7 and has not been returned.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.At this time, we have no reason to suspect that the products 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 risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII MIS DCF AP CT BLK 7
• 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: 11340606
• MDR Text Key: 232303219
• Report Number: 1020279-2021-01381
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497239
• UDI-Public: 03596010497239
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441155
• Device Catalogue Number: 71441155
• Device Lot Number: 04KM03321
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention