MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 6; PRSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICSTRAIND,UNCMNTD,PORS,COATD,POLYMR/METL/POLYMR

Catalog Number 71440820

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2018

Event Type  Injury  

Event Description

It was reported that during a case, the product in question was being placed on the patient and impacted.The bone spike detached from the block and was left in the patient.The surgeon used an osteotome to remove some bone around the spike so it could be removed.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A clinical evaluation indicated that insufficient clinically relevant documentation was provided, therefore a thorough medical assessment could not be performed.Should additional information become available, the clinical/medical task may be re-evaluated.A visual inspection of the returned gii post ref block indicated that the cutting block exhibited wear in each of the cutting slots and damage to the impactor connection point which are consistent with product use.One of the cutting blocks bone spikes fractured at the cutting block interface.The fracture of the bone spike is likely due to stresses in excess of its material properties being applied to the bone spike during use.This device was manufactured in 2009, showing sign of wear/use.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 complaint history on the listed part revealed no prior complaints for the listed batch.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 further 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
• Type of Device: PRSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICSTRAIND,UNCMNTD,PORS,COATD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 7931820
• MDR Text Key: 122557682
• Report Number: 1020279-2018-01954
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Report Date: 02/05/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71440820
• Device Lot Number: 09EM02889
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention