MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 6

Model Number	190-30-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during the initial implantation of a tha, on this female patient after countersinking a size 6 broach in the patient's femoral canal the surgeon asked for a size 6 collared stem.While attempting to seat the implant to reproduce the position of the broach the patient's femur cracked.He then extracted the implant, applied cables to the femur and went through extensive broaching and re-broaching to get the implant to fit.This caused 30-45 mins delay in surgery.Patient was last known to be in stable condition following the event.Devices not returning, it is implanted into the patient.
Additional Manufacturer Narrative
(h3) the evaluation of the of the reported event was, the surgical technique and patient conditions at the time of implantation of the total hip components.No information provided in the following section(s): a2, a4, a5, b6.The following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: ALTEON
• Common Device Name: ALT HA S CLR STD SZ 6
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10972479
• Report Number: 1038671-2020-00644
• Device Sequence Number: 4282976
• Product Code: MEH
• UDI-Device Identifier: 10885862321084
• UDI-Public: 10885862321084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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 Expiration Date: 02/22/2025
• Device Model Number: 190-30-06
• Device Catalogue Number: 190-30-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention