MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PIN PULLER SYRINGE STYLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRULIANT PIN PULLER SYRINGE STYLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during surgical use the truliant pin puller broke during a truliant tka.The pin puller was engaged with the pin and upon pulling the pin vertically up out of the tibia tray the pin puller inner prong broke.The broken prong was isolated and removed from the sterile field.There were no parts or pieces of the device fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The pin puller is not usable and is being returned to exactech.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g4, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken truliant pin pullers reported in were likely the result of 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 and/or off-axis loading when the user applies a bending moment to the device during pin driving/pulling.

• Brand Name: TRULIANT PIN PULLER SYRINGE STYLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32656
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13338207
• Report Number: 1038671-2022-00039
• Device Sequence Number: 19858777
• Product Code: LXH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT PIN PULLER SYRINGE STYLE
• Device Catalogue Number: 02-029-90-4100
• Device Lot Number: 152066055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female