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

Model Number	TRULIANT PIN PULLER SYRINGE STYLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
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
During surgical use, surgeon was placing a tibia pin into the tray when the small silver pin grabbers broke.Immediately the pin puller pieces were removed, and a new pin puller was opened for them to continue surgery.Patient was last known to be in stable condition following the event.The device will be returned.
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, CEMENTED
• 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: 12857959
• Report Number: 1038671-2021-00628
• Device Sequence Number: 11766906
• Product Code: JWH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• 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): 12/29/2021

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: 93388007
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Unknown