MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; FIT TRAY ADJ, TIBIAL TAMP HEAD, NET SHAPE

Catalog Number	213-75-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted under capa(b)(4): the investigation concluded that the root cause of the tibial tamp head fractures was a combination of the design and a user misuse issue.Revision a of the tibial tamp head has a sharp corner present that could create a stress concentration that contributes to the breakage of the device.The surgical technique instructs that use of the extraction lever and ¿mauldin multi-tool¿ should be used to extract the tibial tamp head from the bone.The surgical technique does not specifically state that the surgeon should not hit the tamp handle/guide backwards (retro-grade) to remove the tamp assembly from the bone.As a correction, the company has updated the surgical technique to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.E., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.Additionally, the design of the device was modified to add a radius to where the sharp corner was located, to reduce the stress concentration.The capa investigated complaint data to compare occurrence rate of device fractures for revisions a and b of the tibial tamp head.There were no complaints for device fracture for rev.B of the tamp head at the time of the investigation indicating a lower occurrence for device fracture and improved effectiveness.Ifu 700-096-004 states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: appropriate reading of the literature, and training in the operative skills and techniques required for total knee arthroplasty surgery, and reviewing information regarding use of instrumentation.Optetrak operative guide states: the tamp should be ejected from the proximal tibia by squeezing the release lever.If the tamp guide does not disengage from the tibia with the release lever, a mauldin multi-tool can be used to disengage it by inserting the small stud on the end of the mauldin multi-tool into the hole in the handle of the tamp, then rotating the mauldin multi-tool to loosen the tibial tamp.Do not hit the tamp in retrograde.Hitting the tamp in retrograde can result in breakage of the instrument.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or led to patient impact.An investigation was conducted under capa(b)(4); the investigation concluded that the root cause of the tibial tamp head fractures was a combination of the device design and user error issue.
Event or Problem Description
It was reported from (b)(6) that during a bilateral total knee replacement a distal tamp failed ¿through metal fatigue¿.The tamp had to be retrieved from the patient¿s tibia with a pair of vice grips both times as there was only one on the kit.The reporter stated, ¿the part of the tibial tamp that broke looked like metal fatigued was the issue as the small lip on the actual tamp had broken off¿.The device broke on impaction of the tibia and was separated when the tamp was taken from the tibia surface.No pieces/fragments went into the patient¿s operative site, it was captured in the impaction instrument.There was no surgical delay/prolongation, and no injury/ adverse event /clinical consequence to the patient.The patient was stable leaving the operating room.No patient demographic information was provided.No additional information was provided by the contacts related to this event.

• Brand Name: EXACTECH
• Common Device Name: FIT TRAY ADJ, TIBIAL TAMP HEAD, NET SHAPE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11321997
• Report Number: 1038671-2021-00036
• Device Sequence Number: 3248127
• Product Code: LXH
• UDI-Device Identifier: 10885862157584
• UDI-Public: 10885862157584
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: 213-75-01
• Device Lot Number: 51754034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1