MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE; PRSTHSS,KNEE,PTLLO/FMRTIB,SMI-CNSTRND,UNCMNTD,PORS,CTD,POLYMER/METAL/POLYMER

Catalog Number	71440448
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when using the tibial alignment assembly, it was noticed that the ankle clamp would not remain tight within the alignment tube , likely due to over use/age.No harm to patient, no delay occurred, the case finished fine.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned gii tibial alignment tube indicated damage along the body and locking cam, confirming the stated complaint.This device was manufactured in over 23 years ago, showing signs of significant wear from 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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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.

• Brand Name: GII TIBIAL ALIGNMENT TUBE
• Common Device Name: PRSTHSS,KNEE,PTLLO/FMRTIB,SMI-CNSTRND,UNCMNTD,PORS,CTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8282773
• Report Number: 1020279-2019-00312
• Device Sequence Number: 2056053
• Product Code: MBH
• UDI-Device Identifier: 03596010215574
• UDI-Public: 03596010215574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2019

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 Expiration Date: 06/08/2006
• Device Catalogue Number: 71440448
• Device Lot Number: 60709276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1