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	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgical removal of the tibial headed pins for the truliant tibia trial tray, using the pin puller, one of the distal prongs of the pin puller broke.The prong of the pin puller once it broke off fell within the wound onto the tibia tray.The broken prong piece was removed from the wound and the patient.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: based on investigation results, the broken truliant pin puller reported was 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 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14823416
• Report Number: 1038671-2022-00716
• Device Sequence Number: 4612899
• 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): 10/28/2022

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 Model Number: TRULIANT PIN PULLER SYRINGE STYLE
• Device Catalogue Number: 02-029-90-4100
• Device Lot Number: 125032001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 10/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REVISION 4 IN 1 BLOCK HANDLE ATTACHMENT
• Patient Sex: Unknown