MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCUR-TIB BS IMPACT CMNT/PRESS; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71236968
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, plastic on impactor broke when impacting the tibia.Nothing fell into patient.No injury or impact to patient.No delay.No revision surgery performed.Backup device available.
Additional Manufacturer Narrative
The affected tibial base impactor/cement pressurizer was not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2010, which suggests it has been in use for some time.The tibial base impactor is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Without the return of the actual product involved, our investigation of this report is inconclusive.Should additional information be received, the complaint will be reopened.

• Brand Name: ACCUR-TIB BS IMPACT CMNT/PRESS
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8461911
• Report Number: 1020279-2019-01248
• Device Sequence Number: 2839646
• Product Code: HSX
• UDI-Device Identifier: 03596010477194
• UDI-Public: 03596010477194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• 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): 06/22/2019

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 Catalogue Number: 71236968
• Device Lot Number: 10FM04875
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1