MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT PIN PULLER SYRINGE STYLE

Catalog Number	02-029-90-4100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during an initial tka procedure on a male patient, during use of the truliant tibia pin puller to insert headed pins into the trial tibia tray the pa noticed that one of the prongs on the pin puller was broken off.The broken piece of the pin puller was found and contained.There were no pieces left in the patient.A second tibia prep pan was opened to the field to obtain a new pin puller to remove the pins from the bone.The broken pin puller is being returned.The prong of the pin puller fell onto the tibia trial and the pa was able to grab it, and contain it on the back table.The patient left the or stable.The staff took a couple of minutes to look for the broken piece of the prong while waiting for me to grab a new tibia prep pan to get a new pin puller for removal of pins.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the reported event of the broken truliant pin puller was likely the result of: 1) the breakage area of the component being relatively thin which does not offer great safety margin when the instrument is subject to off-axis loading.2) off-axis loading when the user applies a bending moment to the device during pin driving/pulling.No information provided in the following section(s): a2, a4, a5, b6, b7, the following section(s) have additional info: d10, g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Common Device Name: TRULIANT PIN PULLER SYRINGE STYLE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11061039
• Report Number: 1038671-2020-00664
• Device Sequence Number: 1265501
• Product Code: LXH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 02-029-90-4100
• Device Lot Number: 105612050
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention