MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE; PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SMICONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR

Catalog Number	71440448
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the parts need to be forced into position.The block was less securely positioned.A recut was performed because the cut wasn't at the right slope and not at the right angle.It is unknown which of the devices was involved in the medical intervention.
Additional Manufacturer Narrative
The associated gii tibial alignment tubes were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2017.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no clinically relevant documentation was provided; therefore a thorough medical investigation could not be performed.It was communicated that an additional tibial cut was performed due to the locking mechanism needed ¿more force to get closed¿; however, no patient injury was reported with the minimal surgical delay.Should additional clinical information be provided, the clinical/medical task may be re-evaluated.Without the return of the actual product involved, our investigation of this report is inconclusive.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GII TIBIAL ALIGNMENT TUBE
• Common Device Name: PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SMICONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7650729
• Report Number: 1020279-2018-01236
• Device Sequence Number: 19441898
• Product Code: MBH
• UDI-Device Identifier: 03596010215574
• UDI-Public: 03596010215574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71440448
• Device Lot Number: 17ETD0002J
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 12/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Other