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	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during a procedure, a piece from the pin puller fell into the wound site and was immediately removed by the surgeon.There was no surgical delay.The patient was last known to be in stable condition following the event.The product is available for return.
Additional Manufacturer Narrative
H6: investigation determined the broken truliant pin puller reported, 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.Corrective action taken: 1) the design was updated to improve the strength of the breaking area.2) the operative technique was updated to instruct users to avoid using the instrument offaxis.3) a new short-headed pin and an updated syringe pin puller was designed to address the sticking with the baseplate trial while not compromising the strength of the syringe pin puller at the previously broken area.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury, nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• 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: 15254746
• Report Number: 1038671-2022-00943
• Device Sequence Number: 14889561
• Product Code: LXH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 115977007
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 12/11/2025
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 02/07/2023; 12/11/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown