MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PIN PULLER SYRINGE STYLE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

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	03/17/2021
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
As reported, the truliant tibia pin puller had a prong break-off when a headed pin was trying to be removed from the bone within the trial tibia tray.The surgeon was able to get the pin out of the bone using a backup pin puller that was peel packed.There was no delay in the surgery.The patient left the or stable.There were no pieces left in the patient.The broken pin puller and the broken prong were located, identified, and isolated.Patient was last known to be in stable condition following the event.The device is available for return to the company.
Additional Manufacturer Narrative
(h3) the evaluation noted that according to the manufacturer investigation, the device history records of the subject devices were reviewed, and no issues were observed.A design review showed that the breakage area of the component is relatively thin which does not offer great safety margin when the instrument is subject to off-axis loading.Although the evaluation couldn¿t confirm user misuse, off-axis loading which can be generated by the user applying a bending moment to the device during pin driving/pulling could contribute to the breakage.The most likely root cause associated with the reported event are 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.As a correct action, manufacturer have update design to improve strength of breakage area and update operative technique to instruct users to avoid using the instrument off-axis.A risk assessment has been initiated to escalate this issue.

• Brand Name: TRULIANT PIN PULLER SYRINGE STYLE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11625219
• Report Number: 1038671-2021-00155
• Device Sequence Number: 3290977
• Product Code: JWH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1