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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00373.
Event or Problem Description
As reported, the pin puller (cat# 02-029-90-4100) was used to remove the pins out of the tibia.The bone quality was very good and when the surgeon tried to remove the pin, the tip of the pin puller broke off.Furthermore, the fem impactor (02-029-19-1000) was broken on impaction when we were impacting the final femur implant on.One of the sides of the impactor broke off.The surgery was not affected by the breakage.We had backups and the case went very well.Patient was last known to be in stable condition following the event.The devices will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d9, g4, g7, h2, h3 and h6 have been updated accordingly.According to the 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 mis-use, 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 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.A risk assessment has been initiated and corrective actions were taken to update design to improve strength of breakage area 2) update operative technique to instruct users to avoid using the instrument off-axis.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00372 and 1038671-2021-00373.

• 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
• MDR Report Key: 12287891
• Report Number: 1038671-2021-00372
• Device Sequence Number: 19750466
• Product Code: JWH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/13/2021

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: 89895007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1