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

Model Number	02-029-90-4100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, a tibia pin puller was noticed sitting in an extra pain that is kept in sterile processing.It is a tibia pin puller that had a prong from the tip break off in the past.The date/case this happened is unknown.No other information reported.
Additional Manufacturer Narrative
H3: based on the investigation results, the broken truliant pin puller reported in 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.
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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15583600
• Report Number: 1038671-2022-01293
• Device Sequence Number: 5978687
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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: 02-029-90-4100
• Device Catalogue Number: 02-029-90-4100
• Device Lot Number: 125032001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 10/30/2025
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 01/25/2023; 10/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown