MAUDE Adverse Event Report: EXACTECH, INC. MDLR CNLTD TRIDRV DRVR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	315-25-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The instrument could have been broken during the surgery.However, the breakage has been noticed at the recovery of the instrumentation-set by our logistics dept., after the cleaning realized by the sterilization team of the hospital.No information has been received from the hospital regarding this issue and xnov ip didn¿t receive any request for complementary information regarding this issue as well.
Additional Manufacturer Narrative
Pending device return and investigation.
Additional Manufacturer Narrative
H3: the disassembled tri-driver reported was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the tridriver shaft becoming deformed as a result of the sleeve being held stationary while reaming or the sleeve being obstructed by soft tissue or bone.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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: MDLR CNLTD TRIDRV DRVR
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15681176
• Report Number: 1038671-2022-01359
• Device Sequence Number: 20434859
• Product Code: JWH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

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: 315-25-00
• Device Catalogue Number: 315-25-00
• Device Lot Number: 322289001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 10/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 09/02/2025
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 02/28/2023; 09/02/2025
• 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