MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; HOLDING PIN MINI SHARP POINT 4 PK

Catalog Number	201-78-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported during tibial preparation of a initial tkr on a female patient, age and weight unknown, one of the tibial pins would not seem to sink properly into the baseplate/bone.The surgeon tried several times without success which eventually led to a plateau fracture of the tibia.It was discovered afterwards that the tibial pin that caused the issue was oversized and would not fit through the pin holes within the trial tibial baseplate.This oversized pin was what directly caused the fracture.The pin came from a pack of 4 baseplate pins as per the regular process.There is a video attached in the electronic file.
Event or Problem Description
As reported during tibial preparation of a initial tkr on a female patient, age and weight unknown, one of the tibial pins would not seem to sink properly into the baseplate/bone.The surgeon tried several times without success which eventually led to a plateau fracture of the tibia.It was discovered afterwards that the tibial pin that caused the issue was oversized and would not fit through the pin holes within the trial tibial baseplate.This oversized pin was what directly caused the fracture.The pin came from a pack of 4 baseplate pins as per the regular process.The patient was reported to be in satisfactory condition after the procedure.Devices are to be returned for evaluation.All available information available at this time.
Additional Manufacturer Narrative
The evaluation noted the intra-operative bone fracture reported was likely the result of multiple attempts to mate an oversized mini headed fixation pin with the tibial baseplate trial during tibial preparation.No information provided in the following section(s): a2, a4, a5, b6, d4 (serial number), and g5.

• Brand Name: EXACTECH
• Common Device Name: HOLDING PIN MINI SHARP POINT 4 PK
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9368574
• Report Number: 1038671-2019-00581
• Device Sequence Number: 14002543
• Product Code: LXH
• UDI-Device Identifier: 10885862045263
• UDI-Public: 10885862045263
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 201-78-15
• Device Lot Number: 6194439
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention